ORTHOCORD suture is a synthetic, sterile, braided composite suture composed of dyed (D&C Blue #6 or D&C Violet #2) absorbable polydioxnone (PDS) and un-dyed non-absorbable polyethylene. The partially absorbable suture is coated with a copolymer of 90% caprolactone and 10% glycolide.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, specifically a suture. This type of FDA submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that the device meets specific performance acceptance criteria through a clinical study with detailed metrics.

Therefore, many of the requested categories for "acceptance criteria" and "study proving device meets acceptance criteria" are not applicable in this context. The information provided is primarily related to regulatory classification, device description, and a claim of substantial equivalence.

Here's an analysis based on the provided documents:

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Conformance to USP monograph for absorbable sutures	Non-clinical laboratory testing demonstrated conformance to the USP monograph for absorbable sutures.
Substantial equivalence to predicate devices based on indications for use, technological characteristics.	Shown to be substantially equivalent to predicate devices: Orthocord #2 suture (K040004, K043298), Mini OA+ / Minilok QA+ (K071622), and Fiberwire (K021434).
Safety and Performance	Non-clinical laboratory testing was performed demonstrating that the device conformed to the USP monograph for absorbable sutures.

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

Not Applicable. The submission states that "Non-clinical laboratory testing was performed." It does not specify a "test set" in the context of human data, nor does it provide details on sample sizes or data provenance for any testing beyond stating "non-clinical laboratory testing." This generally refers to in-vitro or bench testing, not human clinical trials.

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)

Not Applicable. This information is relevant for studies involving expert review of data (e.g., medical images). The document describes non-clinical laboratory testing, not a study requiring expert-established ground truth.

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

Not Applicable. This applies to studies where human experts are making judgments that need to be reconciled. This is not described in the document.

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

No. An MRMC study is not mentioned. This type of study is relevant for evaluating diagnostic or interpretive AI systems, which is not the nature of this medical device (suture).

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

Not Applicable. This device is a physical medical product (suture), not an algorithm or AI system.

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

Not Applicable. For non-clinical lab testing of a suture, the "ground truth" would be established by physical measurements and material science standards (e.g., tensile strength, knot security, degradation rate) as defined by consensus standards like the USP monograph, rather than clinical outcomes or expert consensus on a diagnostic task.

8. The sample size for the training set

Not Applicable. As this is a physical medical device and not an AI/ML algorithm requiring a training set, this concept does not apply.

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

Not Applicable. See point 8.

Summary

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K080918 page 1/2

510(k) SUMMARY

APR 2 3 2008

Orthocord #2-0 suture with or without needles Submitter's Name and DePuy Mitek a Johnson & Johnson company Address: 325 Paramount Drive Raynham, MA 02767 Contact Person Kristine Christo Regulatory Affairs Project Lead DePuy Mitek a Johnson & Johnson company 325 Paramount Drive Raynham, MA 02767 Telephone: 508 828-3359 508-977-6955 Facsimile: e-mail. KChristo@Dpyus.jnj.com Classification Name: Non-absorbable poly(ethylene terephthalate) Name of Medical Device surgical suture; and Suture, Surgical, Absorbable, Polydioxanone Common/Usual Name: Suture Orthocord suture Proprietary Name: Orthocord #2-0 suture is substantially equivalent to: Substantial Equivalence Orthocord #2 suture (K040004, K043298) manufactured by Mitek; Mini OA+ / Minilok QA+ (K071622) manufactured by Mitek and Fiberwire (K021434) manufactured by Arthrex Sutures, classified by the FDA, are Class II Medical Devices. Device Classification PDS Suture carries an FDA product code NEW, and is classified as absorbable surgical suture, polydiaxanone under 21 CFR 878.4840. Polyethylene suture carries an FDA product code GAT, and is classified under 21 CFR 878.5000. ORTHOCORD suture is a synthetic, sterile, braided composite suture Device Description composed of dyed (D&C Blue #6 or D&C Violet #2) absorbable polydioxnone (PDS) and un-dyed non-absorbable polyethylene. The partially absorbable suture is coated with a copolymer of 90% caprolactone and 10% glycolide.

510(k) Premarket Notification: Special ORTHOCORD #2-0 suture with or without needles

Confidential

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KOBO918 Page 2/2

Indications for Use

Safety and Performance

ORTHOCORD suture is indicated for use in general soft tissue approximation and/or ligation, including use in orthopedic surgeries.

The determination of substantial equivalence for this device was based on a detailed device description, and conformance to consensus and voluntary standards. Non-clinical laboratory testing was performed demonstrating that the device conformed to the USP monograph for absorbable sutures.

Based on the indications for use, technological characteristics, and comparison to predicate devices, the ORTHOCORD suture has been shown to be substantially equivalent to predicate devices under the Federal Food, Drug and Cosmetic Act.

510(k) Premarket Notification: Special ORTHOCORD #2-0 suture with or without needles

Confidential

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Image /page/2/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with flowing lines, representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Depuy Mitek % Ms. Kristine Christo Regulatory Affairs Project Lead 325 Paramount Drive Raynham, Massachusetts 02767

APR 2 3 2008

Re: K080918

Trade/Device Name: Orthocord #2-0 suture with or without needles Regulation Number: 21 CFR 878.4840 Regulation Name: Absorbable polydioxanone surgical suture Regulatory Class: II Product Code: NEW, GAT Dated: March 13, 2008 Received: April 1, 2008

Dear Ms. Christo:

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 (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. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 -- Ms. Kristine Christo

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Mark M. Milliman

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

510(k) Number (if known): K080918

Device Names: Orthocord #2-0 suture with or without needles

Indications for Use:

. . . . .

Orthocord #2-0 suture is indicated for use in general soft tissue approximation and/or ligation, including use in orthopedic surgeries.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices

Page 1 of 1

510(k) Number	K080918
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510(k) Premarket Notification
ORTHOCORD #2-0 suture
with or without needles
Confidential

Regulation Number and Section

§ 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.