(272 days)
-
PINION™ PDO Knotless Sutures are indicated for use in general soft tissue approximation where use of an absorbable suture is appropriate.
-
PINION™ PGA-PCL Knotless Sutures are indicated for use in general soft tissue approximation where use of an absorbable suture is appropriate.
The PINION™ PDO Knotless Suture consists of barbed suture material armed with a surgical needle on each end. Barbs allow for tissue approximation without the need to tie surgical knots. PINION™ PDO Knotless Suture is a sterile, synthetic, absorbable monofilament suture comprised of Poly (p- Polydioxanone). The empirical molecular formula of which is (G.HგO3)x. PINION™ PDO Knotless Sutures are available in undyed or dyed with D & C violet No.2 (21 CFR 74. 3602) at a level not exceeding 0.3 % by weight of the suture in sizes USP (EP) 3-0 (2), 2-0 (3) & 0 (3.5). It is supplied with the attached stainless steel surgical needles. Polydioxanone has been found to be nonantigenic, nonpyrogenic and to elicit only a slight tissue reaction during absorption. The PINION™ PDO Knotless Suture is designed with small unidirectional and bidirectional barbs along the length of the device. It consists of an absorbable thread with unidirectional anchors, equipped with a surgical needle at one end and a fixation tab at the other while the bidirectional anchors equipped with a surgical needle at both end. The anchors and fixation tab design allows for tissue approximation without the need to tie surgical knots.
The PINION™ PGA-PCL Knotless Suture consists of barbed suture material armed with a surgical needle on each end. Barbs allow for tissue approximation without the need to tie surgical knots. PINION™ PGA-PCL Knotless Suture is a sterile, synthetic, absorbable monofilament suture comprised of poly (glycolide-co-caprolactone). PINION™ PGA-PCL Knotless Suture is provided undyed or dyed with D & C violet No.2 (21 CFR 74. 3602) at a level not exceeding 0.25 % by weight of the suture in sizes USP (EP) 4-0 (1.5), 3-0 (2) & 2-0 (3). It is supplied with the attached stainless steel surgical needles. The polymer has been found to be nonantigenic, nonpyrogenic and eliciting only a slight tissue reaction during absorption. The PINION™ PGA-PCL Knotless Suture is designed with small unidirectional and bidirectional barbs along the length of the device. It consists of an absorbable thread with unidirectional anchors, equipped with a surgical needle at one end and a fixation tab at the other while the bidirectional anchors equipped with a surgical needle at both end. The anchors and fixation tab design allows for tissue approximation without the need to tie surgical knots.
The provided text describes the acceptance criteria and the studies performed for two medical devices: PINION™ PDO Knotless Suture and PINION™ PGA-PCL Knotless Suture.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The main acceptance criteria are based on comparison to predicate devices and adherence to USP (United States Pharmacopoeia) and ISO standards. The "Reported Device Performance" column reflects whether the subject device meets these criteria. Since the document states "No change," "Identical," or indicates the subject device provides "more safety" than the predicate device, it implies successful meeting of the criteria.
PINION™ PDO Knotless Suture
| Acceptance Criteria | Reported Device Performance (Subject Device) |
|---|---|
| General Characteristics | |
| Device Name / Manufacturer / 510(K) Number | PINION™ PDO Knotless Suture / Meril EndoSurgery Pvt. Ltd. / K232246 (Identical for these categories when comparing subject to predicate, but these are identifying info specific to the subject device, not performance) |
| Common Name | Absorbable Polydioxanone surgical suture (No change from predicate) |
| Class / Product Code / Regulation Number | II / NEW / CFR 878.4840 (No change from predicate) |
| Intended use | Indicated for use in general soft tissue approximation where use of an absorbable suture is appropriate. (Identical to predicate) |
| For single use only | Single use only (No change from predicate) |
| Mode of Actions (Tensile strength retention & absorption) | Approximately 70-80% of original strength remains after two and four weeks. 40-50% retained at six weeks. Minimal absorption until ~120 days, complete within 180 days (six months). (Identical to predicate's performance) |
| Material composition | poly (p-dioxanone) (No change from predicate) |
| Body Contact | Tissue/Bone/Blood (No change from predicate) |
| Shelf Life | 5 Year (No change from predicate) |
| Size availability | 3-0 to 0 (Covered by the predicate suture range) |
| Absorbable/Non Absorbable | Absorbable (No change from predicate) |
| Braided/Monofilament | Monofilament (No change from predicate) |
| Dyed / Undyed | Undyed or Dyed Suture Strands (No change from predicate) |
| Colorant | D&C Violet No. 2 (No change from predicate) |
| Coated / Uncoated | Uncoated (No change from predicate) |
| Types of Barbs | Uni-directional, Bi-directional (No change from predicate) |
| No. of barbs per linear length of Suture | 13-17 barbs per cm (More than predicate's 10 barbs per cm, providing "more safety") |
| Barb Angle (3-0, 2-0, 0) | 3-0: 23 -28 (∠°) Different from predicate (40-50, 35-45, 35-45 respectively), but "do not raise new questions of safety and effectiveness as the average barb holding strength for the subject is equivalent to that of the predicate device." |
| 2-0: 23 -28 (∠°) | |
| 0: 23 -28 (∠°) | |
| Barb Height (3-0, 2-0, 0) | 3-0: 0.250-0.350 mm Different from predicate (0.400-0.550, 0.400-0.550, 0.400-0.550 respectively), but "do not raise new questions of safety and effectiveness as the average barb holding strength for the subject is equivalent to that of the predicate device." |
| 2-0: 0.300-0.400 mm | |
| 0: 0.350-0.450 mm | |
| Barb Shape | Cog Shape (No change from predicate) |
| Barb Direction (Bidirectional) | A section and B section in opposite direction. (No change from predicate) |
| Barb Direction (Unidirectional) | A section and B section in same direction. (No change from predicate) |
| Complete Absorption | within 180 to 210 days (No change from predicate) |
| Sterilization method | Ethylene Oxide (No change from predicate) |
| Needle Material | Stainless Steel (No change from predicate) |
| Packaging | Primary and Secondary packaging described are identical to predicate. (Identical) |
| Label Claim | Complies with USP for "Synthetic Absorbable Surgical Suture" (except for diameter) (No change from predicate) |
| Diameter USP <861> | Meets performance requirementsdefined in USP <861>, except for diameter for some oversize suture. (Identical to predicate) |
| Tensile strength USP <881> | Meets performance requirementsdefined in USP <881>. (No change from predicate) |
| Needle attachment USP <871> | Meets performance requirementsdefined in USP <871>. (No change from predicate) |
| Labeling and Instructions for use (IFU). | Conforming to 21CFR 801.109 and USP, includes indications, warnings, adverse reactions, contraindication and precautions. (No change from predicate) |
| Biocompatibility | Comply with ISO 10993-1 (No change from predicate) |
PINION™ PGA-PCL Knotless Suture
| Acceptance Criteria | Reported Device Performance (Subject Device) |
|---|---|
| General Characteristics | |
| Device Name / Manufacturer / 510(K) Number | PINION™ PGA PCL Knotless Suture / Meril EndoSurgery Pvt. Ltd. / K232246 (Identical for these categories when comparing subject to predicate, but these are identifying info specific to the subject device, not performance) |
| Common Name | Absorbable poly(glycolide/l-lactide) surgical suture (No change from predicate) |
| Class / Product Code / Regulation Number | II / GAM / 21 CFR 878.4493 (No change from predicate) |
| Intended use | Indicated for use in soft tissue approximation where the use of absorbable suture is appropriate. (Identical to predicate) |
| For single use only | Single use only (No change / Identical) |
| Mode of Actions (Tensile strength retention & absorption) | Retains approximately 62% of original strength 7 days post implantation. Loses all original tensile strength by 28 days. Absorption essentially completed between 90 and 120 days. (Comparable to predicate performance of 62% at 7 days, 27% at 14 days, and complete absorption by 91 days) |
| Material composition | Copolymer of (glycolide and ε caprolactone)(PGA-PCL) (No change from predicate) |
| Body Contact | Tissue/Bone/Blood (No change from predicate) |
| Shelf Life | 5 Year (No change from predicate) |
| Size availability | 4-0 to 2-0 (No change from predicate) |
| Absorbable/Non Absorbable | Absorbable (No change from predicate) |
| Braided/Monofilament | Monofilament (No change from predicate) |
| Dyed / Undyed | Undyed or Dyed Suture Strands (No change from predicate) |
| Colorant (if Dyed) | D&C Violet No. 2 (No change from predicate) |
| Coated / Uncoated | Uncoated (No change from predicate) |
| Types of Barbs | Uni-directional, Bi-directional (Both types covered by predicate device) |
| No. of barbs per linear length of Suture | 17-22 barbs per cm (More than predicate's 10 barbs per cm, providing "more safety") |
| Barb Angle (4-0, 3-0, 2-0) | 4-0: Not specified, but generally 23-38 (∠°) Different from predicate (whose angles are 23-38 (∠°), but "do not raise new questions of safety and effectiveness as the average barb holding strength for the subject is equivalent to that of the predicate device." |
| 3-0: Not specified, but generally 23-38 (∠°) | |
| 2-0: Not specified, but generally 23-38 (∠°) | |
| Barb Height (4-0, 3-0, 2-0) | 4-0: 0.253-0.283 mm Different from predicate (0.350-0.550 mm), but "do not raise new questions of safety and effectiveness as the average barb holding strength for the subject is equivalent to that of the predicate device." |
| 3-0: 0.250-0.350 mm | |
| 2-0: 0.300-0.400 mm | |
| Barb Shape | Cog Shape (No change from predicate) |
| Barb Direction (Bidirectional) | A section and B section in opposite direction. (No change from predicate) |
| Barb Direction (Unidirectional) | A section and B section in same direction. (No change from predicate) |
| Absorption Profile | between 90 and 120 days (Identical / Comparable to predicate's "essentially complete by 91 days") |
| Sterilization method | Ethylene Oxide (Identical to predicate) |
| Needle Material | Stainless Steel (Identical to predicate) |
| Packaging Configuration | Primary and Secondary packaging described are identical to predicate. (Identical) |
| Label Claim | Complies with USP for "Synthetic Absorbable Surgical Suture" (except for diameter) (Identical to predicate) |
| Diameter USP <861> | Meets performance requirementsdefined in USP <861>, except for diameter for some oversize suture. (Identical to predicate) |
| Tensile strength USP <881> | Meets performance requirementsdefined in USP <881>. (Identical to predicate) |
| Needle attachment USP <871> | Meets performance requirementsdefined in USP <871>. (Identical to predicate) |
| Labeling and Instructions for use (IFU). | Conforming to 21CFR 801.109 and USP, includes indications, warnings, adverse reactions, contraindication and precautions. (Identical to predicate) |
| Biocompatibility | Comply with ISO 10993-1 (Identical to predicate) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document details performance testing for both sutures, including:
- Diameter USP <861>
- Tensile strength USP <881>
- Needle attachment USP <871>
- Suture Length
- Number of barbs per linear length of suture
- Barb size (length)
- Barb size Direction
- Barb Angle
- Barb holding strength
- Sterility USP <71>
- Biocompatibility as per ISO 10993-1
However, the specific sample sizes used for each of these performance tests are not explicitly stated in the provided document.
The document mentions "implantation studies in animals" for the predicate devices to establish in-vivo tensile strength retention and absorption profiles. For the subject devices, it explicitly mentions "The results of in vitro study using PINION™ PDO Knotless Suture" and "PINION™ PGA-PCL Knotless Suture retains approximately 62 % of its original strength 7 days post implantation," implying similar in-vitro or animal studies were conducted for the subject devices to demonstrate equivalent performance.
The data provenance is related to the manufacturing country, which is India (M/s. Meril Endo Surgery Private Limited, Gujarat, India). The studies would therefore likely align with standard regulatory practices and be conducted to meet FDA requirements for prospective testing to demonstrate device performance and safety. The document does not specify if any retrospective data was used for direct performance comparison of the subject device, beyond referencing predicate device characteristics.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This section is not applicable to this type of medical device submission. The devices are surgical sutures, and their performance is evaluated through measurable physical and biological properties against established standards (USP, ISO) and comparison to predicate devices, not through expert-reviewed interpretations of images or clinical outcomes that require "ground truth" established by human experts in the same way an AI diagnostic device would.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving human readers and AI for diagnostic or screening tasks to establish a consensus "ground truth." For surgical sutures, the assessments are based on objective physical measurements and biological tests, not subjective interpretations requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This section is not applicable. MRMC studies are relevant for diagnostic or screening devices, particularly those involving AI assistance for human readers. These sutures are physical medical devices, not diagnostic software.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This section is not applicable. This question pertains to AI/software device performance, which is not relevant to surgical sutures.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For these surgical sutures, the "ground truth" or reference standards are:
- United States Pharmacopoeia (USP) standards for properties like diameter, tensile strength, and needle attachment.
- ISO 10993-1 standards for biocompatibility.
- Established performance profiles of the legally marketed predicate devices (e.g., STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Device and STRATAFIX™ Spiral MONOCRYL™ Knotless Tissue Control Device) for characteristics like tensile strength retention and absorption rates.
These are objective, quantitative and scientifically established benchmarks or comparisons.
8. The sample size for the training set
This section is not applicable. "Training set" refers to data used to train machine learning models. Surgical sutures are physical devices, not AI/ML systems, and therefore do not have training sets.
9. How the ground truth for the training set was established
This section is not applicable for the same reason as above.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size, also in blue.
April 25, 2024
M/s. Meril Endo Surgery Private Limited Asma Shaikh Assistant Manager- Regulatory Affairs Third Floor, E1-E3, Meril Park Survey No. 135/2/B & 174/2. Muktanand Marg. Chala Vapi, Gujarat 396191 India
Re: K232246
Trade/Device Name: 1) PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture: 2) PINION™ PGA-PCL Knotless Suture - Absorbable Polyglycolic Acid - Poly (Glycolide-Co-Caprolactone) Knotless Suture Regulation Number: 21 CFR 878.4840 Regulation Name: Absorbable Polydioxanone Surgical Suture Regulatory Class: Class II Product Code: NEW, GAM Dated: July 28, 2023 Received: March 25, 2024
Dear Asma Shaikh:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn).
Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/deviceadvice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for
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more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Digitally signed by Tek N. Tek N. Lamichhane -S Lamichhane -S Date: 2024.04.25 15:43:22 -04'00' Tek N. Lamichhane, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Submission Number (if known)
Device Name
- PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; 2) PINION™ PGA-PCL Knotless Suture - Absorbable Poly (Glycolide-Co-Caprolactone) Knotless Suture
Indications for Use (Describe)
-
PINION™ PDO Knotless Sutures are indicated for use in general soft tissue approximation where use of an absorbable suture is appropriate.
-
PINION™ PGA-PCL Knotless Sutures are indicated for use in general soft tissue approximation where use of an absorbable suture is appropriate.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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I. SUBMITTER
M/s. Meril Endo Surgery Private Limited. Third Floor, E1 – E3, Meril Park, Survey No. 135/2/B & 174/2, Muktanand Marg, Chala, Vapi – 396191 Gujarat, India. Tel. No: +91-260-3052100, Fax: +91-260-3052125 Web site: www.merillife.com
Applicant Information
Mr. Umesh Sharma
General Manager – Quality Assurance / Regulatory Affairs
E-mail: umesh.sharma@merillife.com
Primary Correspondent Information
Asma Shaikh
Assistant Manager – Regulatory Affairs
E-mail: asma.shaikh@merillife.com
Date Prepared: April 24th, 2024
II. SUBJECT DEVICE
| Trade / Proprietary Name | PINION™ PDO Knotless Suture |
|---|---|
| Common Name | Suture, Surgical, Absorbable Polydioxanone |
| Classification | Absorbable Polydioxanone Surgical Suture |
| Regulatory Class | II |
| Product Code | NEW |
| Regulation Number | 21 CFR 878.4840 |
| Review Panel | General & Plastic Surgery Devices Panel |
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| Trade / Proprietary Name | PINION™ PGA-PCL Knotless Suture |
|---|---|
| Common Name | Suture, Surgical, Absorbable Polyglycolic Acid |
| Classification | Absorbable poly(glycolide/l-lactide) surgical suture |
| Regulatory Class | II |
| Product Code | GAM |
| Regulation Number | 21 CFR 878.4493 |
| Review Panel | General & Plastic Surgery Devices Panel |
III. PREDICATE DEVICE
| Subject device(K232246) | Trade Name | Predicate deviceManufacturer | 510 (K) No. |
|---|---|---|---|
| PINION™ PDOKnotless Suture | STRATAFIX™ SymmetricPDS™ Plus Knotless TissueControl Device | Ethicon Inc. | K182873 |
| PINION™ PGA-PCLKnotless Suture | STRATAFIX™ SpiralMONOCRYL™ KnotlessTissue ControlDevice(Primary Predicate) | Ethicon Inc. | K151200 |
| STRATAFIX™ SpiralMONOCRYL™ PlusUnidirectional KnotlessTissueControl Device | K221744 |
IV. Device Description
PINION™ PDO KNOTLESS SUTURE
The PINION™ PDO Knotless Suture consists of barbed suture material armed with a surgical needle on each end. Barbs allow for tissue approximation without the need to tie surgical knots.
PINION™ PDO Knotless Suture is a sterile, synthetic, absorbable monofilament suture comprised of Poly (p- Polydioxanone). The empirical molecular formula of which is (G.HგO3)x. PINION™ PDO Knotless Sutures are available in undyed or dyed with D & C violet No.2 (21 CFR 74. 3602) at a level not exceeding 0.3 % by weight of the suture in sizes USP (EP) 3-0 (2), 2-0 (3) & 0 (3.5). It is supplied with the attached stainless steel surgical needles. Polydioxanone has been found to be nonantigenic, nonpyrogenic and to elicit only a slight tissue reaction during absorption.
The PINION™ PDO Knotless Suture is designed with small unidirectional and bidirectional barbs along the length of the device. It consists of an absorbable thread with unidirectional anchors, equipped with a
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surgical needle at one end and a fixation tab at the other while the bidirectional anchors equipped with a surgical needle at both end. The anchors and fixation tab design allows for tissue approximation without the need to tie surgical knots.
The USP designations for diameter are applicable to the PINION™ PDO Knotless Suture material prior to barbing. After the creation of barbs, the PINION™ PDO Knotless Suture is identified as one size smaller than the non-barbed suture. This modification reduces the tensile strength of the suture similar to effect of knot tying in non-barbed suture. Therefore, the straight pull tensile strength of the PINION™ PDO Knotless Suture is comparable to the USP knot pull tensile strength for a non barbed suture of the equivalent size. The non-barbed size and equivalent size of the PINION™ PDO Knotless Suture is further clarified in Table 1.
The maximum oversize for non barbed suture material from the USP Size is further detailed in Table 2.
The PINION™ PDO Knotless Suture meets requirements established by the United States Pharmacopoeia (USP) for Synthetic absorbable sutures for needle attachments only.
| PINION™ PDOKnotless Suture | Pre-Barbing Suture Size | Equivalent Non-barbedSuture Size(USP)/Tensile Strength(kgf) |
|---|---|---|
| 3-0 | 2-0 | 3-0/1.77 |
| 2-0 | 0 | 2-0/2.68 |
| 0 | 1 | 0/3.90 |
Tensile Strength/Size Equivalency Table 1
Maximum Oversize for non-barbed suture material in diameter (mm) from USP Table 2
| PINION™ PDOKnotless Suture | USP Size Designations(mm) | PINION™ PDOKnotless SutureDiameter Specification(mm) |
|---|---|---|
| 3-0 | 0.200-0.249 | 0.300-0.349 |
| 2-0 | 0.300-0.349 | 0.350-0.399 |
| 0 | 0.350-0.399 | 0.400-0.499 |
The PINION™ PDO Knotless Suture is MR Safe.
PINION™ PGA-PCL KNOTLESS SUTURE
The PINION™ PGA-PCL Knotless Suture consists of barbed suture material armed with a surgical needle on each end. Barbs allow for tissue approximation without the need to tie surgical knots.
PINION™ PGA-PCL Knotless Suture is a sterile, synthetic, absorbable monofilament suture comprised of poly (glycolide-co-caprolactone).
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PINION™ PGA-PCL Knotless Suture is provided undyed or dyed with D & C violet No.2 (21 CFR 74. 3602) at a level not exceeding 0.25 % by weight of the suture in sizes USP (EP) 4-0 (1.5), 3-0 (2) & 2-0 (3). It is supplied with the attached stainless steel surgical needles. The polymer has been found to be nonantigenic, nonpyrogenic and eliciting only a slight tissue reaction during absorption.
The PINION™ PGA-PCL Knotless Suture is designed with small unidirectional and bidirectional barbs along the length of the device. It consists of an absorbable thread with unidirectional anchors, equipped with a surgical needle at one end and a fixation tab at the other while the bidirectional anchors equipped with a surgical needle at both end. The anchors and fixation tab design allows for tissue approximation without the need to tie surgical knots.
The USP designations for diameter are applicable to the PINION™ PGA-PCL Knotless Suture material prior to barbing. After the creation of barbs, the PINION™ PGA-PCL Knotless Suture is identified as one size smaller than the non-barbed suture. This modification reduces the tensile strength of the suture similar to effect of knot tying in non-barbed suture. Therefore, the straight pull tensile strength of the PINION™ PGA-PCL Knotless Suture is comparable to the USP knot pull tensile strength for a non barbed suture of the equivalent size. The non-barbed size and equivalent size of the PINION™ PGA-PCL Knotless Suture is further clarified in Table 1.
The maximum oversize for non barbed suture material from the USP Size is further detailed in Table 2.
The PINION™ PGA-PCL Knotless Suture meets requirements established by the United States Pharmacopoeia (USP) for Synthetic absorbable sutures for needle attachments only.
|--|
| PINION™ PGA-PCL KnotlessSuture | Pre-Barbing Suture Size | Equivalent Non-barbedSuture Size(USP)/Tensile Strength(kgf) |
|---|---|---|
| 4-0 | 3-0 | 4-0/0.95 |
| 3-0 | 2-0 | 3-0/1.77 |
| 2-0 | 0 | 2-0/2.68 |
Maximum Oversize for non-barbed suture material in diameter (mm) from USP Table 2
| PINION™ PGA-PCL KnotlessSuture | USP Size Designations(mm) | PINION™ PGA-PCLKnotless SutureDiameter Range (mm) |
|---|---|---|
| 4-0 | 0.150-0.199 | 0.200-0.249 |
| 3-0 | 0.200-0.249 | 0.300-0.349 |
| 2-0 | 0.300-0.349 | 0.350-0.399 |
The PINION™ PGA-PCL Knotless Suture is MR Safe.
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V. Indications for Use
PINION™ PDO Knotless Sutures are indicated for use in general soft tissue approximation where use of an absorbable suture is appropriate.
PINION™ PGA-PCL Knotless Sutures are indicated for use in general soft tissue approximation where use of an absorbable suture is appropriate.
VI. Comparison of Technological Characteristics with the predicate device
The PINION™ PDO & PINION™ PGA-PCL Knotless Sutures are substantially equivalent to marketed predicate device with respect to intended use and physical characteristics. The PINION™ PGA-PCL Knotless Sutures have same material, mechanism of action, performance and packaging as predicate devices.
The following characteristics were compared between the subject device and the predicate device in order to demonstrate the substantial equivalence.
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The below table provides the comparison of key features of the subject device and predicate devices.
Table 1: PINION™ PDO Knotless Suture
| Sr.No. | Characteristics | Subject Device | Predicate Device | Safety / Effectiveness | |
|---|---|---|---|---|---|
| 1. | Device Name | PINION™ PDO Knotless Suture | STRATAFIX™ Symmetric PDS™ PlusKnotless Tissue Control Device | - | |
| 2. | Manufacturer | Meril EndoSurgery Pvt. Ltd. | Ethicon Inc. | - | |
| 3. | 510(K) Number | K232246 | K182873 | - | |
| 4. | Common Name | Absorbable Polydioxanone surgicalsuture | Absorbable Polydioxanone surgicalsuture | No change | |
| 5. | Class | II | II | No change | |
| 6. | Product Code | NEW | NEW | No change | |
| 7. | Regulation Number | CFR 878.4840 | CFR 878.4840 | No change | |
| 8. | Intended use | PINION™ PDO Knotless Suture isindicated for use in general soft tissueapproximation where use of anabsorbable suture use is appropriate. | STRATAFIX™ Symmetric PDS™ PlusKnotless Tissue Control Devices areindicated for general soft tissueapproximation where use of anabsorbable suture is appropriate. | Identical | |
| 9. | For single use only | Single use only | Single use only | No change | |
| 10 | Mode of Actions | Two important characteristicsdescribe the in vivo performance ofabsorbable sutures: first, tensilestrength retention and second, theabsorption rate (loss of mass).PINION™ PDO Knotless Suture hasbeen formulated to minimize thevariability of these characteristics andto provide wound support throughthe critical wound healing period and | Two important characteristics describethe in vivo performance of absorbablesutures: first, tensile strength retentionand second, the absorption rate (lossof mass). STRATAFIX™ SymmetricPDS™ Plus Knotless Tissue ControlDevices has been formulated tominimize the variability of thesecharacteristics and to provide woundsupport through the critical wound | Identical | |
| K232246 | |||||
| Sr.No. | Characteristics | Subject Device | Predicate Device | Safety / Effectiveness | |
| an extended healing period.The results of in vitro study usingPINION™ PDO Knotless Sutureindicate that approximately 70-80% ofthe original strength remains aftertwo weeks and four weeks of study.At six weeks approximately 40-50% ofthe original strength is retained.The absorption of PINION™ PDOKnotless Suture is minimal until about120 days and complete absorptionusually takes place within 180 days(six months). | healing period and an extendedhealing period.The results of implantation studies inanimals using STRATAFIX™ SymmetricPDS™ Plus Knotless Tissue ControlDevices indicates that for sizes 3-0 andlarger, approximately 80 % of theoriginal strength remains after twoweeks and four weeks of implantation.At six weeks post implantation,approximately 40% to 70% of theoriginal strength is retained. For Size 4-0, approximately 67 % of the originaltensile strength remains after twoweeks, approximately 50% at 4 weeks,and approximately 37 % at 6 weeks.Data obtained from implantationstudies show that absorption ofSTRATAFIX™ Symmetric PDS™ PlusKnotless Tissue Control Devices isminimal until about 120 days and isessentially complete within 180 days(six months). | ||||
| 11 | Material composition | poly (p-dioxanone) | poly (p-dioxanone) | No change | |
| 12 | Body Contact | Tissue/Bone/Blood | Tissue/Bone/Blood | No change | |
| 13 | Shelf Life | 5 Year | 5 Year | No change | |
| 14 | Size availability | 3-0 to 0 | 3-0 to 1 | Identical; Suture size iscovered by thePredicate Suture Range | |
| 15 | Absorbable/Non Absorbable | Absorbable | Absorbable | No change | |
| 16 | Braided/ | Monofilament | Monofilament | No change | |
| Sr.No. | Characteristics | Subject Device | Predicate Device | Safety / Effectiveness | |
| Monofilament | |||||
| 17 | Dyed / Undyed | Undyed or Dyed Suture Strands | Undyed or Dyed Suture Strands | No change | |
| 18 | Colorant | D&C Violet No. 2 | D&C Violet No. 2 | No change | |
| 19 | Coated / Uncoated | Uncoated | Uncoated | No change | |
| 20 | Types of Barbs | Uni-directional, Bi-directional | Uni-directional, Bi-directional | No change | |
| 21 | No. of barbs per linear lengthof Suture | 13-17 barbs per cm | 10 barbs per cm | No. of Barbs is more insubject device thanpredicate device whichprovides more safety todevice. | |
| 22 | Barb Angle | 3-0 | Different; While there aredifference in cut anglebetween the subject deviceand the predicate device, thesedo not raise the new questionsof safety and effectivenessas the average barb holdingstrength for the subject isequivalent to that of thepredicate device. | ||
| 2-0 | $40-50 (∠°)$ | $23 -28 (∠°)$ | |||
| 0 | $35-45 (∠°)$ | ||||
| 23 | Barb Height | 3-0 | 0.250-0.350 mm | Different; While there aredifference in Barb Lengthbetween the subject deviceand the predicate device, thesedo not raise the new questionsof safety and effectivenessas the average barb holdingstrength for the subject isequivalent to that of thepredicate device. | |
| 2-0 | 0.300-0.400 mm | 0.400 – 0.550 mm | |||
| 0 | 0.350-0.450 mm | ||||
| 24 | Barb Shape | Cog Shape | Cog Shape | No change | |
| 25 | Barb Direction (Bidirectional) | A section and B section in oppositedirection. | A section and B section in oppositedirection. | No change | |
| 26 | Barb Direction (Unidirectional) | A section and B section in samedirection. | A section and B section in samedirection. | No change | |
| Sr.No. | Characteristics | Subject Device | Predicate Device | Safety / Effectiveness | |
| 27 | Complete Absorption | within 180 to 210 days | within 180 to 210 days | No change | |
| 28 | Sterilization method | Ethylene Oxide | Ethylene Oxide | No change | |
| 29 | Needle Material | Stainless Steel | Stainless Steel | No change | |
| 30 | Packaging | Primary Packaging – Suture is woundon plastic tray and further packed inAluminium Foil and Sealed in Tyvek lid.Secondary Packaging – Primarypacked suture are placed in DispenserBox. | Primary Packaging – Suture is woundon plastic tray and further packed inAluminium Foil and Sealed in Tyvek lid.Secondary Packaging – Primarypacked suture are placed in DispenserBox. | Identical | |
| 31 | Label Claim | Complies with the requirements ofthe United States Pharmacopoeia for"Synthetic Absorbable SurgicalSuture" (except for diameter) | Complies with the requirements of theUnited States Pharmacopoeia for"Synthetic Absorbable Surgical Suture"(except for diameter) | No change | |
| 32 | Diameter USP <861> | Finished suture material meets theperformance requirements defined inthe United States Pharmacopeia forDiameter<861>, except for diameterfor some oversize suture. | Finished suture material meets theperformance requirements defined inthe United States Pharmacopeia forDiameter<861>, except for diameterfor some oversize suture. | Identical | |
| Tensile strength USP <881> | Finished suture material meets theperformance requirements defined inthe United States Pharmacopeia forTensile strength <881>. | Finished suture material meets theperformance requirements defined inthe United States Pharmacopeia forTensile strength <881>.Straight Tensile meets USP KnotTensile requirements for SyntheticAbsorbable Sutures for same suturesize equivalent | No change | ||
| Sr.No. | Characteristics | Subject Device | Predicate Device | Safety / Effectiveness | |
| Needle attachment USP <871> | Finished suture material meets theperformance requirements defined inthe United States Pharmacopeia forNeedle attachment <871>. | Finished suture material meets theperformance requirements defined inthe United States Pharmacopeia forNeedle attachment <871>. | No change | ||
| 33 | Labeling and Instructions foruse (IFU). | Labeling conforming to 21CFR801.109 and USP.IFU includes indications, warnings,adverse reactions, Contraindicationand precautions. | Labeling conforming to 21CFR 801.109and USP.IFU includes indications, warnings,adverse reactions, Contraindicationand precautions | No change | |
| 34 | Biocompatibility | Comply with ISO 10993-1 | Comply with ISO 10993-1 | No change |
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K232246
The PINION™ PGA-PCL Knotless Sutures are substantially equivalent with the predicate devices contained in the following Table 2.
Table 2: PINION™ PGA-PCL Knotless Suture
| Sr.No. | Characteristics | Subject Device | Predicate Device (PrimaryPredicate) | Predicate Device | Safety /Effectiveness | |
|---|---|---|---|---|---|---|
| 1. | Device Name | PINION™ PGA PCLKnotless Suture | STRATAFIX™ Spiral MONOCRYL™Knotless Tissue Control Device | STRATAFIX™ Spiral MONOCRYL™Plus Unidirectional Knotless TissueControl Device | - | |
| 2. | Manufacturer | Meril EndoSurgery Pvt.Ltd. | Ethicon Inc. | Ethicon Inc. | - | |
| 3. | 510(K) Number | K232246 | K151200 | K221744 | - | |
| 4. | Common Name | Absorbablepoly(glycolide/l-lactide)surgical suture | Absorbable poly(glycolide/l-lactide)surgical suture | Absorbable poly(glycolide/I-lactide)surgical suture | No change | |
| 5. | Class | II | II | II | No change | |
| 6. | Product Code | GAM | GAM | GAM | No change | |
| 7. | Regulation | 21 CFR 878.4493 | 21 CFR 878.4493 | 21 CFR 878.4493 | No change | |
| Sr.No. | Characteristics | Subject Device | Predicate Device (PrimaryPredicate) | Predicate Device | Safety /Effectiveness | |
| 8. | Intended use | PINIONTM PGA PCLKnotless Suture isindicated for use in softtissue approximationwhere the use ofabsorbable suture isappropriate. | STRATAFIXTM Spiral MONOCRYLTMKnotless Tissue Control Devices areindicated for use in soft tissueapproximation where the use ofabsorbable suture is appropriate. | STRATAFIXTM Spiral MONOCRYLTMPlus Unidirectional Knotless TissueControl Device is indicated for usein soft tissue approximation wherethe use of absorbable suture isappropriate. | Identical | |
| 9. | For single use only | Single use only | Single use only | Single use only | No changeIdentical | |
| 10. | Mode of Actions | Two importantcharacteristics describethe in vivo performanceof absorbable sutures:first, tensile strengthretention and second,the absorption rate (lossof mass). PINIONTM PDOKnotless Suture hasbeen formulated tominimize the variabilityof these characteristicsand to provide woundsupport through thecritical wound healingperiod and an extendedhealing period.PINIONTM PGA-PCLKnotless Suture retainsapproximately 62 % ofits original strength 7days post implantation | Two important characteristicsdescribe the in vivo performance ofabsorbable sutures: first, tensilestrength retention and second, theabsorption rate (loss of mass).STRATAFIXTM Spiral MONOCRYLTMKnotless Tissue Control Device hasbeen formulated to minimize thevariability of these characteristicsand to provide wound supportthrough the critical wound healingperiod and an extended healingperiod.The results of implantation studiesin animals using STRATAFIXTM SpiralMONOCRYLTM Knotless TissueControl Device indicate thatapproximately 62% of its originalstrength remains after 7 daysimplantation and approximately27% of its original tensile strengthat 14 days post implantation. All ofthe original tensile strength is lost | Two importantcharacteristicsdescribe the in vivo performance ofabsorbable sutures: first, tensilestrength retention and second, theabsorption rate (loss of mass).STRATAFIXTM Spiral MONOCRYLTMPlus Unidirectional Knotless TissueControl Device has been formulatedto minimize the variability of thesecharacteristics and to providewound support through the criticalwound healing period and anextended healing period.The results of implantation studiesin animals using STRATAFIXTM SpiralMONOCRYLTM Knotless TissueTable 3. In Vivo Tensile StrengthProfileDAYS APPROXIMATEIMPLANTATION % ORIGINALSTRENGTH REMAINING | ||
| Sr.No. | Characteristics | Subject Device | Predicate Device (PrimaryPredicate) | Predicate Device | Safety /Effectiveness | |
| of its original tensilestrength at 14 days postimplantation all of theoriginal tensile strengthis lost by 28 days postimplantation. | by 21 days post implantation. Theabsolute strength remaining 14days post implantation meets orexceeds that historically observedwith plain or chromic surgical gutdevices (Table 3). | 14 DaysData obtained from implantationstudies show that absorption ofSTRATAFIX™ Spiral MONOCRYL™Plus Bidirectional Device isessentially complete by 91 days. | Knot TensileStrength27 % of USPKnot TensileStrength | |||
| The absorption ofPINION™ PGA-PCLKnotless Suture isessentially completedbetween 90 and 120days. | Table 3. In Vivo Tensile StrengthProfile | |||||
| DAYSIMPLANTATION | ||||||
| APPROXIMATE% ORIGINALSTRENGTHREMAINING | ||||||
| 7 Days | ||||||
| 62 % of USPKnot TensileStrength | ||||||
| 14 Days | ||||||
| 27 % of USPKnot TensileStrength | ||||||
| Data obtained from implantationstudies show that absorption ofSTRATAFIX™ Spiral MONOCRYL™Plus Bidirectional Device isessentially complete by 91 days. | ||||||
| 11. | Materialcomposition | Copolymer of (glycolideand εcarprolactone)(PGA-PCL) | Copolymer of (glycolide and εcarprolactone)(PGA-PCL) | Copolymer of (glycolide and εcarprolactone)(PGA-PCL) | No change | |
| 12. | Body Contact | Tissue/Bone/Blood | Tissue/Bone/Blood | Tissue/Bone/Blood | No change | |
| 13. | Shelf Life | 5 Year | 5 Year | 5 Year | No change | |
| 14. | Size availability | 4-0 to 2-0 | 4-0 to 2-0 | 4-0 to 2-0 | No change | |
| 15. | Absorbable/Non | Absorbable | Absorbable | Absorbable | No change | |
| Sr.No. | Characteristics | Subject Device | Predicate Device (PrimaryPredicate) | Predicate Device | Safety /Effectiveness | |
| Absorbable | ||||||
| 16. | Braided/Monofilament | Monofilament | Monofilament | Monofilament | No change | |
| 17. | Dyed / Undyed | Undyed or Dyed SutureStrands | Undyed or Dyed Suture Strands | Undyed or Dyed Suture Strands | No change | |
| 18. | Colorant (if Dyed) | D&C Violet No. 2 | D&C Violet No. 2 | D&C Violet No. 2 | No change | |
| 19. | Coated /Uncoated | Uncoated | Uncoated | Uncoated | No change | |
| 20. | Types of Barbs | Uni-directional, Bi-directional | Bi-directional | Uni-directional | Both types arecovered bypredicatedevice | |
| 21. | No. of barbs perlinear length ofSuture | 17-22 barbs per cm | 10 barbs per cm | 10 barbs per cm | No. of Barbs ismore insubject devicethan predicatedevice whichprovides moresafety todevice. | |
| 22 | Barb Angle | 4-03-02-0 | 23 -38 ( $\angle^{\circ}$ ) | Not Known | Different; Whilethere aredifference in cutangle between thesubject device andthe predicatedevice, these donot raise the newquestions of safetyand effectivenessas the average barbholding strength forthe subject isequivalent to thatof the predicatedevice. | |
| Sr.No. | Characteristics | Subject Device | Predicate Device (PrimaryPredicate) | Predicate Device | Safety /Effectiveness | |
| 23. | Barb Height | 4-0 | 0.253-0.283 mm | 0.350 - 0.550 mm | Not Known | Different; Whilethere aredifference in barblength between thesubject device andthe predicatedevice, these donot raise the newquestions of safetyand effectivenessas the average barbholding strength forthe subject isequivalent to thatof the predicatedevice. |
| 3-0 | 0.250-0.350 mm | |||||
| 2-0 | 0.300-0.400 mm | |||||
| 24. | Barb Shape | Cog Shape | Cog Shape | Cog Shape | No change | |
| 25. | Barb Direction(Bidirectional) | A section and B sectionin opposite direction. | A section and B section in oppositedirection. | NA | No change | |
| 26. | Barb Direction(Unidirectional) | A section and B sectionin same direction. | NA | A section and B section in samedirection. | No change | |
| 27. | Absorption Profile | between 90 and 120days. | essentially complete by 91 days. | essentially complete by 91 days. | Identical | |
| 28. | Sterilizationmethod | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide | Identical | |
| 29. | Needle Material | Stainless Steel | Stainless Steel | Stainless Steel | Identical | |
| 30. | PackagingConfiguration | Primary Packaging –Suture is wound onplastic tray and furtherpacked in AluminiumFoil and Sealed in Tyveklid. | Primary Packaging - Suture iswound on plastic tray and furtherpacked in Aluminium Foil andSealed in Tyvek lid.Secondary Packaging - Primarypacked suture are placed in | Primary Packaging - Suture iswound on plastic tray and furtherpacked in Aluminium Foil andSealed in Tyvek lid.Secondary Packaging – Primarypacked suture are placed in | Identical | |
| K232246 | ||||||
| Sr.No. | Characteristics | Subject Device | Predicate Device (PrimaryPredicate) | Predicate Device | Safety /Effectiveness | |
| Primary packed sutureare placed in DispenserBox. | ||||||
| 31. | Label Claim | Complies with therequirements of theUnited StatesPharmacopoeia for"Synthetic AbsorbableSurgical Suture" (exceptfor diameter) | Complies with the requirements ofthe United States Pharmacopoeiafor "Synthetic Absorbable SurgicalSuture" (except for diameter) | Complies with the requirements ofthe United States Pharmacopoeiafor "Synthetic Absorbable SurgicalSuture" (except for diameter) | Identical | |
| Performance | ||||||
| 32. | Diameter USP<861> | Finished suture materialmeets the performancerequirements defined inthe United StatesPharmacopeia forDiameter<861>, exceptfor diameter for someoversize suture. | Finished suture material meets theperformance requirements definedin the United States Pharmacopeiafor Diameter<861>, except fordiameter for some oversize suture. | Finished suture material meets theperformance requirements definedin the United States Pharmacopeiafor Diameter<861>, except fordiameter for some oversize suture. | No change | |
| Tensile strengthUSP <881> | Finished suture materialmeets the performancerequirements defined inthe United StatesPharmacopeia forTensile strength <881>. | Finished suture material meets theperformance requirements definedin the United States Pharmacopeiafor Tensile strength <881>.Straight Tensile meets USP KnotTensile requirements for SyntheticAbsorbable Sutures for same suturesize equivalent. | Finished suture material meets theperformance requirements definedin the United States Pharmacopeiafor Tensile strength <881>.Straight Tensile meets USP KnotTensile requirements for SyntheticAbsorbable Sutures for same suturesize equivalent. | No change | ||
| Needleattachment USP<871> | Finished suture materialmeets the performancerequirements defined inthe United StatesPharmacopeia for | Finished suture material meets theperformance requirements definedin the United States Pharmacopeiafor Needle attachment <871>. | Finished suture material meets theperformance requirements definedin the United States Pharmacopeiafor Needle attachment <871>. | No change | ||
| K232246 | ||||||
| Sr.No. | Characteristics | Subject Device | Predicate Device (PrimaryPredicate) | Predicate Device | Safety /Effectiveness | |
| Needle attachment<871>. | ||||||
| 33. | Labeling andInstructions foruse (IFU). | Labeling conforming to21CFR 801.109 and USP.IFU includes indications,warnings, adversereactions,Contraindication andprecautions. | Labeling conforming to 21CFR801.109 and USP.IFU includes indications, warnings,adverse reactions, Contraindicationand precautions | Labeling conforming to 21CFR801.109 and USP.IFU includes indications, warnings,adverse reactions, Contraindicationand precautions | No change | |
| 34. | Biocompatibility | Comply with ISO 10993-1 | Comply with ISO 10993-1 | Comply with ISO 10993-1 | No change |
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Kク3つ746
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VII. Preclinical Data
Performance Tests
The PINION™ PDO & PINION™ PGA-PCL Knotless Sutures were subjected to the performance testing as per FDA's Special Control Guidance Document for Surgical Sutures, " Surgical Sutures -Class II Special Controls Guidance Document for Industry and FDA Staff June 2, 2003" performance testing including testing in accordance to USP for Absorbable suture and biocompatibility testing of the suture material in accordance to EN ISO 10993-1:2020 has been performed to further ensure substantial equivalence to the predicate devices. The safety and effectiveness of the PINION™ PDO & PINION™ PGA-PCL Knotless Sutures have been evaluated for the following performance and safety requirements.
-
- Diameter USP <861>
-
- Tensile strength USP <881>
-
- Needle attachment USP <871>
-
- Suture Length
-
- Number of barbs per linear length of suture
-
- Barb size (length)
-
- Barb size Direction
-
- Barb Angle
-
- Barb holding strength
-
- Sterility USP <71>
-
- Biocompatibility as per ISO 10993-1
Biocompatibility
The biocompatibility evaluation for PINION™ PDO & PINION™ PGA-PCL Knotless Suture was conducted in accordance with Guidance document 'Use of International Standard ISO 10993-1, "Biological Evaluation of medical devices - Part 1: Evaluation and testing within a risk management process' September 8, 2023 and International Standards ISO 10993-1 "Biological evaluation of Medical Devices Part 1: Evaluation and testing within a risk management process" as recognized by FDA. Biocompatibility testing performed on suture material type for implantable material included Cytotoxicity, Skin Sensitization test, Systemic Toxicity, Genotoxicity Study, In
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vitro Haemolysis test, Implantation test, Material mediated Pyrogenicity, Chronic Toxicity and Carcinogenicity.
The risk assessment for chronic toxicity and carcinogenicity for subject device was evaluated based on the previously 510(K) cleared device (K172659).
The test results and risk assessment suggests that the subject device is biocompatible.
VIII. Conclusion
PINION™ PDO & PINION™ PGA-PCL Knotless Sutures are substantially equivalent to currently marketed device and present no substantial differences in design, material, intended use and function to predicate device.
The performance, biocompatibility, sterilization, packaging and shelf life study conducted on PINION™ PDO & PINION™ PGA-PCL Knotless Sutures demonstrated the device is as safe and as effective as the predicate device. Hence, PINION™ PDO & PINION™ PGA-PCL Knotless will perform as intended in the specified use conditions.
§ 878.4840 Absorbable polydioxanone surgical suture.
(a)
Identification. An absorbable polydioxanone surgical suture is an absorbable, flexible, sterile, monofilament thread prepared from polyester polymer poly (p-dioxanone) and is intended for use in soft tissue approximation, including pediatric cardiovascular tissue where growth is expected to occur, and ophthalmic surgery. It may be coated or uncoated, undyed or dyed, and with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for the device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.