(272 days)
No
The device description and performance studies focus solely on the physical properties and biocompatibility of the suture material and design. There is no mention of any computational or analytical functions that would involve AI or ML.
No.
The device is a surgical suture used for approximation of soft tissue, not for treating a disease or condition.
No
Explanation: The device is described as a "knotless suture" used for "general soft tissue approximation," indicating it is a surgical tool for closing wounds or tissues, not for diagnosing conditions.
No
The device description clearly details a physical, absorbable suture with barbs and attached surgical needles, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "general soft tissue approximation where use of an absorbable suture is appropriate." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The device is a "barbed suture material armed with a surgical needle on each end." This is a physical implantable device used to hold tissue together.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health. The description of the PINION™ sutures does not involve any testing of biological samples.
- Performance Studies: The performance studies focus on the physical properties of the suture (diameter, tensile strength, needle attachment, barb characteristics) and its biocompatibility when implanted in the body. These are typical evaluations for surgical implants, not IVDs.
Therefore, the PINION™ PDO and PGA-PCL Knotless Sutures are surgical devices intended for direct use in the body, not for in vitro diagnostic testing.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
NEW, GAM
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.HգO3)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 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™ 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).
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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" and biocompatibility testing of the suture material in accordance to EN ISO 10993-1:2020. The test results and risk assessment suggests that the subject device is biocompatible.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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.
1
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
2
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
3
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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4
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 |
5
| 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 device
Manufacturer | 510 (K) No. |
|------------------------------------|--------------------------------------------------------------------------------------------|----------------------------------|-------------|
| PINION™ PDO
Knotless Suture | STRATAFIX™ Symmetric
PDS™ Plus Knotless Tissue
Control Device | Ethicon Inc. | K182873 |
| PINION™ PGA-PCL
Knotless Suture | STRATAFIX™ Spiral
MONOCRYL™ Knotless
Tissue Control
Device(Primary Predicate) | Ethicon Inc. | K151200 |
| | STRATAFIX™ Spiral
MONOCRYL™ Plus
Unidirectional Knotless
Tissue
Control 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
6
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™ PDO
Knotless Suture | Pre-Barbing Suture Size | Equivalent Non-barbed
Suture 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™ PDO
Knotless Suture | USP Size Designations
(mm) | PINION™ PDO
Knotless Suture
Diameter 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).
7
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 Knotless
Suture | Pre-Barbing Suture Size | Equivalent Non-barbed
Suture 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 Knotless
Suture | USP Size Designations
(mm) | PINION™ PGA-PCL
Knotless Suture
Diameter 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.
8
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.
9
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™ Plus | ||
| Knotless Tissue Control Device | - | ||||
| 2. | Manufacturer | Meril EndoSurgery Pvt. Ltd. | Ethicon Inc. | - | |
| 3. | 510(K) Number | K232246 | K182873 | - | |
| 4. | Common Name | Absorbable Polydioxanone surgical | |||
| suture | Absorbable Polydioxanone surgical | ||||
| suture | 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 is | |||
| indicated for use in general soft tissue | |||||
| approximation where use of an | |||||
| absorbable suture use is appropriate. | STRATAFIX™ Symmetric PDS™ Plus | ||||
| Knotless Tissue Control Devices are | |||||
| indicated for general soft tissue | |||||
| approximation where use of an | |||||
| absorbable suture is appropriate. | Identical | ||||
| 9. | For single use only | Single use only | Single use only | No change | |
| 10 | Mode of Actions | Two important characteristics | |||
| describe the in vivo performance of | |||||
| absorbable sutures: first, tensile | |||||
| strength retention and second, the | |||||
| absorption rate (loss of mass). | |||||
| PINION™ PDO Knotless Suture has | |||||
| been formulated to minimize the | |||||
| variability of these characteristics and | |||||
| to provide wound support through | |||||
| the critical wound healing period and | Two important characteristics describe | ||||
| the in vivo performance of absorbable | |||||
| sutures: first, tensile strength retention | |||||
| and second, the absorption rate (loss | |||||
| of mass). STRATAFIX™ Symmetric | |||||
| PDS™ Plus Knotless Tissue Control | |||||
| Devices has been formulated to | |||||
| minimize the variability of these | |||||
| characteristics and to provide wound | |||||
| support 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 using | |||||
| PINION™ PDO Knotless Suture | |||||
| indicate that approximately 70-80% of | |||||
| the original strength remains after | |||||
| two weeks and four weeks of study. | |||||
| At six weeks approximately 40-50% of | |||||
| the original strength is retained. | |||||
| The absorption of PINION™ PDO | |||||
| Knotless Suture is minimal until about | |||||
| 120 days and complete absorption | |||||
| usually takes place within 180 days | |||||
| (six months). | healing period and an extended | ||||
| healing period. | |||||
| The results of implantation studies in | |||||
| animals using STRATAFIX™ Symmetric | |||||
| PDS™ Plus Knotless Tissue Control | |||||
| Devices indicates that for sizes 3-0 and | |||||
| larger, approximately 80 % of the | |||||
| original strength remains after two | |||||
| weeks and four weeks of implantation. | |||||
| At six weeks post implantation, | |||||
| approximately 40% to 70% of the | |||||
| original strength is retained. For Size 4- | |||||
| 0, approximately 67 % of the original | |||||
| tensile strength remains after two | |||||
| weeks, approximately 50% at 4 weeks, | |||||
| and approximately 37 % at 6 weeks. | |||||
| Data obtained from implantation | |||||
| studies show that absorption of | |||||
| STRATAFIX™ Symmetric PDS™ Plus | |||||
| Knotless Tissue Control Devices is | |||||
| minimal until about 120 days and is | |||||
| essentially 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 is | |
| covered by the | |||||
| Predicate 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 length | ||||
| of Suture | 13-17 barbs per cm | 10 barbs per cm | No. of Barbs is more in | ||
| subject device than | |||||
| predicate device which | |||||
| provides more safety to | |||||
| device. | |||||
| 22 | Barb Angle | 3-0 | Different; While there are | ||
| difference in cut angle | |||||
| between the subject device | |||||
| and the predicate device, these | |||||
| do not raise the 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 | $40-50 (∠°)$ | $23 -28 (∠°)$ | |||
| 0 | $35-45 (∠°)$ | ||||
| 23 | Barb Height | 3-0 | 0.250-0.350 mm | Different; While there are | |
| difference in Barb Length | |||||
| between the subject device | |||||
| and the predicate device, these | |||||
| do not raise the 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 | 0.400 – 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 opposite | |||
| direction. | A section and B section in opposite | ||||
| direction. | No change | ||||
| 26 | Barb Direction (Unidirectional) | A section and B section in same | |||
| direction. | A section and B section in same | ||||
| direction. | 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 wound | |||
| on plastic tray and further packed in | |||||
| Aluminium Foil and Sealed in Tyvek lid. | |||||
| Secondary Packaging – Primary | |||||
| packed suture are placed in Dispenser | |||||
| Box. | Primary Packaging – Suture is wound | ||||
| on plastic tray and further packed in | |||||
| Aluminium Foil and Sealed in Tyvek lid. | |||||
| Secondary Packaging – Primary | |||||
| packed suture are placed in Dispenser | |||||
| Box. | Identical | ||||
| 31 | Label Claim | Complies with the requirements of | |||
| the United States Pharmacopoeia for | |||||
| "Synthetic Absorbable Surgical | |||||
| Suture" (except for diameter) | Complies with the requirements of the | ||||
| United States Pharmacopoeia for | |||||
| "Synthetic Absorbable Surgical Suture" | |||||
| (except for diameter) | No change | ||||
| 32 | Diameter USP | Finished suture material meets the | |||
| performance requirements defined in | |||||
| the United States Pharmacopeia for | |||||
| Diameter, except for diameter | |||||
| for some oversize suture. | Finished suture material meets the | ||||
| performance requirements defined in | |||||
| the United States Pharmacopeia for | |||||
| Diameter, except for diameter | |||||
| for some oversize suture. | Identical | ||||
| Tensile strength USP | Finished suture material meets the | ||||
| performance requirements defined in | |||||
| the United States Pharmacopeia for | |||||
| Tensile strength . | Finished suture material meets the | ||||
| performance requirements defined in | |||||
| the United States Pharmacopeia for | |||||
| Tensile strength . | |||||
| Straight Tensile meets USP Knot | |||||
| Tensile requirements for Synthetic | |||||
| Absorbable Sutures for same suture | |||||
| size equivalent | No change | ||||
| Sr. | |||||
| No. | Characteristics | Subject Device | Predicate Device | Safety / Effectiveness | |
| Needle attachment USP | Finished suture material meets the | ||||
| performance requirements defined in | |||||
| the United States Pharmacopeia for | |||||
| Needle attachment . | Finished suture material meets the | ||||
| performance requirements defined in | |||||
| the United States Pharmacopeia for | |||||
| Needle attachment . | No change | ||||
| 33 | Labeling and Instructions for | ||||
| use (IFU). | Labeling conforming to 21CFR | ||||
| 801.109 and USP. | |||||
| IFU includes indications, warnings, | |||||
| adverse reactions, Contraindication | |||||
| and precautions. | Labeling conforming to 21CFR 801.109 | ||||
| and USP. | |||||
| IFU includes indications, warnings, | |||||
| adverse reactions, Contraindication | |||||
| and precautions | No change | ||||
| 34 | Biocompatibility | Comply with ISO 10993-1 | Comply with ISO 10993-1 | No change |
10
11
12
13
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 (Primary
Predicate) | Predicate Device | Safety /
Effectiveness | |
|------------|------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1. | Device Name | PINION™ PGA PCL
Knotless Suture | STRATAFIX™ Spiral MONOCRYL™
Knotless Tissue Control Device | STRATAFIX™ Spiral MONOCRYL™
Plus Unidirectional Knotless Tissue
Control Device | - | |
| 2. | Manufacturer | Meril EndoSurgery Pvt.
Ltd. | Ethicon Inc. | Ethicon Inc. | - | |
| 3. | 510(K) Number | K232246 | K151200 | K221744 | - | |
| 4. | Common Name | Absorbable
poly(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 (Primary
Predicate) | Predicate Device | Safety /
Effectiveness | |
| 8. | Intended use | PINIONTM PGA PCL
Knotless Suture is
indicated for use in soft
tissue approximation
where the use of
absorbable suture is
appropriate. | STRATAFIXTM Spiral MONOCRYLTM
Knotless Tissue Control Devices are
indicated for use in soft tissue
approximation where the use of
absorbable suture is appropriate. | STRATAFIXTM Spiral MONOCRYLTM
Plus Unidirectional Knotless Tissue
Control Device is indicated for use
in soft tissue approximation where
the use of absorbable suture is
appropriate. | Identical | |
| 9. | For single use only | Single use only | Single use only | Single use only | No change
Identical | |
| 10. | Mode of Actions | Two important
characteristics describe
the in vivo performance
of absorbable sutures:
first, tensile strength
retention and second,
the absorption rate (loss
of mass). PINIONTM PDO
Knotless Suture has
been formulated to
minimize the variability
of these characteristics
and to provide wound
support through the
critical wound healing
period and an extended
healing period.
PINIONTM PGA-PCL
Knotless Suture retains
approximately 62 % of
its original strength 7
days post implantation | Two important characteristics
describe the in vivo performance of
absorbable sutures: first, tensile
strength retention and second, the
absorption rate (loss of mass).
STRATAFIXTM Spiral MONOCRYLTM
Knotless Tissue Control Device has
been formulated to minimize the
variability of these characteristics
and to provide wound support
through the critical wound healing
period and an extended healing
period.
The results of implantation studies
in animals using STRATAFIXTM Spiral
MONOCRYLTM Knotless Tissue
Control Device indicate that
approximately 62% of its original
strength remains after 7 days
implantation and approximately
27% of its original tensile strength
at 14 days post implantation. All of
the original tensile strength is lost | Two important
characteristics
describe the in vivo performance of
absorbable sutures: first, tensile
strength retention and second, the
absorption rate (loss of mass).
STRATAFIXTM Spiral MONOCRYLTM
Plus Unidirectional Knotless Tissue
Control Device has been formulated
to minimize the variability of these
characteristics and to provide
wound support through the critical
wound healing period and an
extended healing period.
The results of implantation studies
in animals using STRATAFIXTM Spiral
MONOCRYLTM Knotless Tissue
Table 3. In Vivo Tensile Strength
Profile
DAYS APPROXIMATE
IMPLANTATION % ORIGINAL
STRENGTH REMAINING | | |
| Sr.
No. | Characteristics | Subject Device | Predicate Device (Primary
Predicate) | Predicate Device | Safety /
Effectiveness | |
| | | of its original tensile
strength at 14 days post
implantation all of the
original tensile strength
is lost by 28 days post
implantation. | by 21 days post implantation. The
absolute strength remaining 14
days post implantation meets or
exceeds that historically observed
with plain or chromic surgical gut
devices (Table 3). | 14 Days
Data obtained from implantation
studies show that absorption of
STRATAFIX™ Spiral MONOCRYL™
Plus Bidirectional Device is
essentially complete by 91 days. | Knot Tensile
Strength
27 % of USP
Knot Tensile
Strength | |
| | | The absorption of
PINION™ PGA-PCL
Knotless Suture is
essentially completed
between 90 and 120
days. | Table 3. In Vivo Tensile Strength
Profile | | | |
| | | | DAYS
IMPLANTATION | | | |
| | | | APPROXIMATE
% ORIGINAL
STRENGTH
REMAINING | | | |
| | | | 7 Days | | | |
| | | | 62 % of USP
Knot Tensile
Strength | | | |
| | | | 14 Days | | | |
| | | | 27 % of USP
Knot Tensile
Strength | | | |
| | | | Data obtained from implantation
studies show that absorption of
STRATAFIX™ Spiral MONOCRYL™
Plus Bidirectional Device is
essentially complete by 91 days. | | | |
| 11. | Material
composition | Copolymer of (glycolide
and ε
carprolactone)(PGA-
PCL) | Copolymer of (glycolide and ε
carprolactone)(PGA-PCL) | Copolymer of (glycolide and ε
carprolactone)(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 (Primary
Predicate) | Predicate Device | Safety /
Effectiveness | |
| | Absorbable | | | | | |
| 16. | Braided/
Monofilament | Monofilament | Monofilament | Monofilament | No change | |
| 17. | Dyed / Undyed | Undyed or Dyed Suture
Strands | 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 are
covered by
predicate
device | |
| 21. | No. of barbs per
linear length of
Suture | 17-22 barbs per cm | 10 barbs per cm | 10 barbs per cm | No. of Barbs is
more in
subject device
than predicate
device which
provides more
safety to
device. | |
| 22 | Barb Angle | 4-0
3-0
2-0 | 23 -38 ( $\angle^{\circ}$ ) | Not Known | Different; While
there are
difference in cut
angle between the
subject device and
the predicate
device, these do
not raise the new
questions of safety
and effectiveness
as the average barb
holding strength for
the subject is
equivalent to that
of the predicate
device. | |
| Sr.
No. | Characteristics | Subject Device | | Predicate Device (Primary
Predicate) | Predicate Device | Safety /
Effectiveness |
| 23. | Barb Height | 4-0 | 0.253-
0.283 mm | 0.350 - 0.550 mm | Not Known | Different; While
there are
difference in barb
length between the
subject device and
the predicate
device, these do
not raise the 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 | | | |
| 24. | Barb Shape | Cog Shape | | Cog Shape | Cog Shape | No change |
| 25. | Barb Direction
(Bidirectional) | A section and B section
in opposite direction. | | A section and B section in opposite
direction. | NA | No change |
| 26. | Barb Direction
(Unidirectional) | A section and B section
in same direction. | | NA | A section and B section in same
direction. | No change |
| 27. | Absorption Profile | between 90 and 120
days. | | essentially complete by 91 days. | essentially complete by 91 days. | Identical |
| 28. | Sterilization
method | Ethylene Oxide | | Ethylene Oxide | Ethylene Oxide | Identical |
| 29. | Needle Material | Stainless Steel | | Stainless Steel | Stainless Steel | Identical |
| 30. | Packaging
Configuration | | Primary Packaging –
Suture is wound on
plastic tray and further
packed in Aluminium
Foil and Sealed in Tyvek
lid. | Primary Packaging - Suture is
wound on plastic tray and further
packed in Aluminium Foil and
Sealed in Tyvek lid.
Secondary Packaging - Primary
packed suture are placed in | Primary Packaging - Suture is
wound on plastic tray and further
packed in Aluminium Foil and
Sealed in Tyvek lid.
Secondary Packaging – Primary
packed suture are placed in | Identical |
| K232246 | | | | | | |
| Sr.
No. | Characteristics | Subject Device | Predicate Device (Primary
Predicate) | Predicate Device | Safety /
Effectiveness | |
| | | Primary packed suture
are placed in Dispenser
Box. | | | | |
| 31. | Label Claim | Complies with the
requirements of the
United States
Pharmacopoeia for
"Synthetic Absorbable
Surgical Suture" (except
for diameter) | Complies with the requirements of
the United States Pharmacopoeia
for "Synthetic Absorbable Surgical
Suture" (except for diameter) | Complies with the requirements of
the United States Pharmacopoeia
for "Synthetic Absorbable Surgical
Suture" (except for diameter) | Identical | |
| | Performance | | | | | |
| 32. | Diameter USP
| Finished suture material
meets the performance
requirements defined in
the United States
Pharmacopeia for
Diameter, except
for diameter for some
oversize suture. | Finished suture material meets the
performance requirements defined
in the United States Pharmacopeia
for Diameter, except for
diameter for some oversize suture. | Finished suture material meets the
performance requirements defined
in the United States Pharmacopeia
for Diameter, except for
diameter for some oversize suture. | No change | |
| | Tensile strength
USP | Finished suture material
meets the performance
requirements defined in
the United States
Pharmacopeia for
Tensile strength . | Finished suture material meets the
performance requirements defined
in the United States Pharmacopeia
for Tensile strength .
Straight Tensile meets USP Knot
Tensile requirements for Synthetic
Absorbable Sutures for same suture
size equivalent. | Finished suture material meets the
performance requirements defined
in the United States Pharmacopeia
for Tensile strength .
Straight Tensile meets USP Knot
Tensile requirements for Synthetic
Absorbable Sutures for same suture
size equivalent. | No change | |
| | Needle
attachment USP
| Finished suture material
meets the performance
requirements defined in
the United States
Pharmacopeia for | Finished suture material meets the
performance requirements defined
in the United States Pharmacopeia
for Needle attachment . | Finished suture material meets the
performance requirements defined
in the United States Pharmacopeia
for Needle attachment . | No change | |
| | K232246 | | | | | |
| Sr.
No. | Characteristics | Subject Device | Predicate Device (Primary
Predicate) | Predicate Device | Safety /
Effectiveness | |
| | | Needle attachment
. | | | | |
| 33. | Labeling and
Instructions for
use (IFU). | Labeling conforming to
21CFR 801.109 and USP.
IFU includes indications,
warnings, adverse
reactions,
Contraindication and
precautions. | Labeling conforming to 21CFR
801.109 and USP.
IFU includes indications, warnings,
adverse reactions, Contraindication
and precautions | Labeling conforming to 21CFR
801.109 and USP.
IFU includes indications, warnings,
adverse reactions, Contraindication
and precautions | No change | |
| 34. | Biocompatibility | Comply with ISO 10993-
1 | Comply with ISO 10993-1 | Comply with ISO 10993-1 | No change | |
14
15
16
17
18
19
Kク3つ746
20
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
-
- Tensile strength USP
-
- Needle attachment USP
-
- Suture Length
-
- Number of barbs per linear length of suture
-
- Barb size (length)
-
- Barb size Direction
-
- Barb Angle
-
- Barb holding strength
-
- Sterility USP
-
- 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
21
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.