(272 days)
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PINION™ PDO Knotless Sutures are indicated for use in general soft tissue approximation where use of an absorbable suture is appropriate.
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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 | Meets performance requirementsdefined in USP , except for diameter for some oversize suture. (Identical to predicate) |
| Tensile strength USP | Meets performance requirementsdefined in USP . (No change from predicate) |
| Needle attachment USP | Meets performance requirementsdefined in USP . (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 | Meets performance requirementsdefined in USP , except for diameter for some oversize suture. (Identical to predicate) |
| Tensile strength USP | Meets performance requirementsdefined in USP . (Identical to predicate) |
| Needle attachment USP | Meets performance requirementsdefined in USP . (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
- 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
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.
§ 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.