OPTIME® R sutures are intended for use in general soft tissue approximation including ophthalmic procedures, but not in cardiovascular or neurological procedures.

Device Description

OPTIME®R sutures are intended to be used in suturing in open or laparoscopic surgery. These sutures are available with a disposable needle attachment. OPTIME®R is a sterile, multiple-stranded (multifilament), synthetic bioabsorbable thread made from a polymerization of polyglycolic acid (PGA) used in suturing when short-term support and rapid strength loss are needed. To perform suturing on soft tissue wounds involves a series of precise steps. The surgeon grasps the needle, pushes it through tissue, pulls it through and repeats for continuous suturing. Further, knots are tied, excess thread is cut, and used needles are single use and safely disposed in accordance with hospital procedure.

AI/ML Overview

The provided text is an FDA 510(k) Pre-Market Notification for a medical device called OPTIME® R, which is an absorbable surgical suture. The document primarily focuses on establishing substantial equivalence to a predicate device (Safil Quick Aesculap, K031286) based on technological characteristics and performance testing.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance:

The document states that the OPTIME® R suture was subjected to the requirements of the United States Pharmacopeia (U.S.P) monograph for Synthetic Absorbable Sutures. The following tests and their corresponding USP standards are mentioned:

Acceptance Criteria / Test	Reported Device Performance
Diameter (following USP 43 <861>)	Meets USP performance requirements for absorbable sutures
Tensile strength (following USP 43 <881>)	Meets USP performance requirements for absorbable sutures
Needle attachment (following USP 43 <871>)	Meets USP performance requirements for absorbable sutures
Length (following USP 43 - Absorbable surgical suture)	Meets USP performance requirements for absorbable sutures
Resorption properties	Essentially complete at 42 days (matches predicate's absorption time)
Biocompatibility (following ISO 10993)	Biocompatibility tests performed and results indicate compliance
Sterilization methods	Gamma sterilization (matches predicate)
Shelf-life	5 years
Ideal storage	Stored in original packaging, <25°C, dry, protected from light
Packaging	36 units/carton, individual units in tearable aluminum pouch, then secondary pouch

Specific details about the exact numerical acceptance criteria (e.g., minimum tensile strength in Newtons, acceptable diameter range in mm) are not explicitly provided in this document beyond stating compliance with USP standards. The document broadly indicates that the device "meets USP performance requirements."

2. Sample size used for the test set and the data provenance:

The document does not specify the sample sizes used for the Diameter, Tensile Strength, Needle Attachment, Length, or Resorption testing.
The data provenance is from Peters Surgical, a French company (Immeuble Aurélium, 1 course de l'Ile Seguin, Boulogne-Billancourt, Hauts-De-Seine 92100 France). The studies appear to be prospective testing conducted by the manufacturer to demonstrate compliance. There is no mention of country of origin of the data beyond the manufacturer's location.

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 information is not applicable in this context. The "ground truth" for a medical device like a surgical suture is established by objective engineering and biological performance standards (USP, ISO) rather than expert consensus on interpretation. There are no images or subjective assessments involved that would require expert adjudication or establishing ground truth in the way it's typically described for AI/diagnostic devices.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This is not applicable. As mentioned above, the tests are objective measurements against predefined standards. There is no subjective assessment 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 is not applicable. OPTIME® R is an absorbable surgical suture, a physical medical device, not an AI or diagnostic software. Therefore, MRMC studies are not relevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

This is not applicable. OPTIME® R is a physical surgical suture, not an algorithm or AI product.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for this device's performance is based on established national and international standards for absorbable sutures. Specifically:
- United States Pharmacopeia (USP) monographs for physical and mechanical properties (Diameter, Tensile Strength, Needle Attachment, Length).
- ISO 10993 series for biocompatibility (Cytotoxicity, Sensitization, Irritation, Material mediated pyrogenicity, Acute Systemic Toxicity, Sub-acute/sub-chronic Toxicity, Genotoxicity, Chemical characterization and toxicological risk assessment, Implantation, Degradation).
- Resorption time is a characteristic feature verified against the predicate and established through testing.

8. The sample size for the training set:

This is not applicable. There is no "training set" as this is a physical device, not a machine learning model.

9. How the ground truth for the training set was established:

This is not applicable for the same reason as point 8.

Summary

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October 11, 2024

Peters Surgical Vikram Verma Regulatory Consultant for Peters Surgical Immeuble AURELIUM. 1 course de 1'lle Seguim Boulogne-Billancourt, Hauts-De-Seine 92100 France

Re: K233265

Trade/Device Name: Optime® R Regulation Number: 21 CFR 878.4493 Regulation Name: Absorbable poly(glycolide/l-lactide) surgical suture Regulatory Class: Class II Product Code: GAM Dated: September 12, 2024 Received: September 13, 2024

Dear Vikram Verma:

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.

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.

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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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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 medical devices and radiation-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-device-advice-comprehensive-regulatory

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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Tek N. Digitally signed by Tek N. Lamichhane -S Lamichhane - Date: 2024.10.11 S 16:05:30 -04'00'

Tek N. Lamichhane, Ph.D. Assistant Director DHT4B: Division of 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

510(k) Number (if known) K233265

Device Name OPTIME® R

Indications for Use (Describe)

OPTIME® R sutures are intended for use in general soft tissue approximation including ophthalmic procedures, but not in cardiovascular or neurological procedures.

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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Abbreviated 510(k) Summary- K233265

In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CRF 807.92, this information serves as a Summary of Safety and Effectiveness for the use of OPTIME®R Device.

1. Applicant:

PETERS SURGICAL Immeuble Aurélium, 1 Cours de l'Ile Seguin, 92100 Boulogne-Billancourt France

2. Official Correspondent

Marie Compagnon Riobé Immeuble Aurélium 1 cours de l'Ile Seguin 92100 Boulogne-Billancourt, France Phone : +33 1 48 10 62 23 Email : m.compagnon-riobe@peters-surgical.com

3. Regulatory Correspondent/ 510(k) Submission Contact

Vikram Verma Global Regulatory Compliance 240 Annette Ave, Woonsocket, RI 02895 Email: vikver2000@yahoo.com Phone: 978-602-6239

4. Date Prepared: October 11, 2024

5. Device Information:

Device Trade Name	Common Name	Regulatory Classification	Device Class	Product Code	Panel	Predicate Device
OPTIME®R	Absorbable SurgicalSuture, coatedPolyglycolicAcid braid withfast resorption	AbsorbablePoly(glycolide/l-lactide) SurgicalSuture (21 CFR878.4493)	II	GAM	GeneralandPlasticSurgery	Safil QuickAesculapK031286

6. Device Description:

OPTIME®R sutures are intended to be used in suturing in open or laparoscopic surgery.

These sutures are available with a disposable needle attachment.

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OPTIME®R is a sterile, multiple-stranded (multifilament), synthetic bioabsorbable thread made from a polymerization of polyglycolic acid (PGA) used in suturing when short-term support and rapid strength loss are needed. To perform suturing on soft tissue wounds involves a series of precise steps. The surgeon grasps the needle, pushes it through tissue, pulls it through and repeats for continuous suturing. Further, knots are tied, excess thread is cut, and used needles are single use and safely disposed in accordance with hospital procedure.

7. Indication for Use:

OPTIME®R sutures are intended for use in general soft tissue approximation including ophthalmic procedures, but not in cardiovascular or neurological procedures.

8. Comparison of Technological Characteristics

The Absorbable Suture OPTIME®R device is substantially equivalent to the predicate device listed above table in term of intended use, design, performance and principle of operation when compared to the technological characteristics and is available in similar configurations and materials. Below the comparison table specifies substantial equivalence comparison between proposed device and predicate device. Any differences between OPTIME®R suture and it's predicate device are insignificant and do not raise any issues regarding safety or performance of OPTIME®R Surgical Suture.

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OPTIME® R Comparison of technological characteristics to the predicate device:

ComparativeCharacteristics	Proposed Device : OPTIME® R	Predicate Device: Safil Quick
510(k) Number	K233265	K031286
Classification	General and Plastic Surgery	General and Plastic Surgery
DeviceDescription	OPTIME® R device is an absorbablesynthetic surgical implantablesuture. The sutures are undyed,sterile comprised of rapidlyresorbing coated polyglycolic acidbraid.	Safil Quick device is an absorbable, flexiblemultifilament suture thread which is supplieddyed, undyed, and sterile. It is composed of asynthetic polyglycolic acid polymer, and it isindicated for soft tissue approximation whereonly short-term wound support is required.
Product Code	GAM	GAM
Indication forUse	OPTIME® R synthetic absorbablesurgical sutures are indicated for usein general soft tissue approximation,including in ophthalmic procedures,but not in cardiovascular orneurological procedures.	Safil Quick sutures are indicated for use in generalsoft tissue approximation,including ophthalmic procedures, but not incardiovascular or neurological procedures.
Regulation	21 CFR 878.4493	21 CFR 878.4493
Regulatory Class	Class II	Class II
Single Use	Yes	Yes
Principle DeviceComponents(Sterile,Disposable andSingle Use)	Thread with attached needle	Thread with attached needle
Type of Device(Material Used)	Absorbable PGA (Polyglycolic acids)suture	Absorbable PGA (Polyglycolic acids) suture
BiocompatibilityRequirements	ISO 10993	ISO 10993
Sterilizationmethods	Gamma	Gamma
Technical Features/Design
Thread material	PGA - Polyglycolic Acid	PGA - Polyglycolic Acid
Thread coating	Coating composed of a mixture ofpolycaprolactone and calciumstearate (≤ 5%)	Polyglyconate coating
Thread size	USP 6/0 to USP 1	USP 7/0 to USP 2
Thread length	45 cm to 90 cm	30 cm to 250 cm
Dyeing of thread	Undyed	Undyed
Needlesmaterials	Stainless Steel (silver or blackcolored)	Stainless Steel (silver colored)
Needle coating	Silicone coated	Information not publicly available
Needlecurvatures	1/2, 3/8, and straight	1/2, 1/4, 3/8, 5/8, and straight
Needle points	Cutting, taper cutting, taper andextracut	Taper point, reverse cutting, trocar point, cutting,round, micro-lancet
Needle length	11 mm to 50 mm	6 mm to 51 mm
Absorption time	Absorption of the sutures OPTIME®	Absorption of SAFIL® QUICK takes place after
	R is essentially complete at 42 days	approximately 42 days.
Shelf-life	5 years	Information not publicly available
Ideal storage	Must be stored in its originalpackaging, at a temperature below25°C, in a dry place and protectedfrom light	Information not publicly available
Package description	36 devices units per carton box Onedevice unit is placed in cardboardsupport inside a tear able aluminumpouch which is placed inside asecondary pouch of paper/PE peelpouch	12 or 36 devices units per box Devices placed incardboard support inside a tear able aluminumpouch inside a paper/PE peel pouch

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9. Summary of Testing

As per the FDA's Class II Special Control Guidance Document for Surgical Sutures, the subject device was subjected to the requirements of the United States Pharmacopeia (U.S.P) monograph for Synthetic Absorbable Sutures.

Testing included:

Diameter following USP 43 <861>
Tensile strength following USP 43 <881>
Needle attachment following USP 43 <871>
. Length following USP 43- Absorbable surgical suture

Stability testing has been completed.

Results of USP performance and resorption testing demonstrate that the subject device meets USP performance requirements for absorbable sutures and is substantially equivalent to its predicate device.

The biological evaluation of OPTIME®R was performed in accordance with FDA guidance on the use of ISO 10993-1. The following test reports were provided in this submission:

Cytotoxicity
Sensitization
Irritation
Material mediated pyrogenicity
Acute Systemic Toxicity
Sub-acute/sub-chronic Toxicity
Genotoxicity
Chemical characterization and toxicological risk assessment
Implantation
Degradation

10. Conclusion

Based on the information provided within this 510(k) submission, Peters Surgical concludes that:

OPTIME®R is substantially equivalent to the predicate device Safil Quick Synthetic Absorbable Surgical Suture (K031286).

Regulation Number and Section

§ 878.4493 Absorbable poly(glycolide/l-lactide) surgical suture.

(a)
Identification. An absorbable poly(glycolide/l-lactide) surgical suture (PGL suture) is an absorbable sterile, flexible strand as prepared and synthesized from homopolymers of glycolide and copolymers made from 90 percent glycolide and 10 percent l-lactide, and is indicated for use in soft tissue approximation. A PGL suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. “Monograph for Absorbable Surgical Sutures;” it may be monofilament or multifilament (braided) in form; it may be uncoated or coated; and it may be undyed or dyed with an FDA-approved color additive. Also, the suture may be provided with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for this 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.