The polyblend surgical suture meets USP requirements as described in the USP monograph for nonabsorbable surgical sutures. CP Medical non-absorbable polyblend surgical sutures made with a braided, twisted core of polyethylene terephthalate and a polyethylene cover, are available in sterile form to an SAL of 106. Sterilization is performed by either Ethylene Oxide or Gamma Irradiation.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called "CP Fiber, Non-Absorbable Polyblend Surgical Suture." This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving safety and effectiveness through clinical trials with specific acceptance criteria as you might see for novel devices.

Therefore, the information you're requesting regarding acceptance criteria, study details, sample sizes, and expert ground truth is not applicable to this document. This submission primarily relies on comparing the new device's characteristics and performance to already approved predicate devices.

However, I can extract information related to the device and its equivalence to the predicate:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: The primary acceptance criterion for this 510(k) submission is substantial equivalence to the predicate devices. This means the new device must meet the same performance standards as the predicate devices and be suitable for the same indications for use. Specifically, it must meet USP requirements for nonabsorbable sutures.
Reported Device Performance (from text):
- Device Type: Non-absorbable polyblend surgical suture.
- Composition: Braided, twisted core of polyethylene terephthalate and a polyethylene cover.
- Sterility: Available in sterile form to an SAL of 10^-6 (Sterility Assurance Level). Sterilization by Ethylene Oxide or Gamma Irradiation.
- USP Compliance: Meets USP requirements as described in the USP monograph for nonabsorbable surgical sutures.
- Predicate Device Compliance: Both predicate and proposed devices are indicated for use in soft tissue approximation; both meet USP for nonabsorbable sutures, may be silicone-coated or uncoated, and may be dyed or undyed with an appropriate FDA listed color additive. The sutures may also be provided with or without a standard needle attached.

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

Not applicable. This 510(k) submission does not describe a test set or clinical study in the manner implied by these questions. Equivalence is primarily demonstrated through material properties, manufacturing processes, and adherence to recognized standards (like USP) that are common to the predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. There is no mention of a "test set" requiring expert-established ground truth in this submission.

4. Adjudication method for the test set:

Not applicable. No test set requiring adjudication is described.

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:

Not applicable. This is a surgical suture, not an imaging or diagnostic device that would typically involve human readers or AI assistance.

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

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

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

Not applicable. The "ground truth" here is the established performance and safety profile of the predicate devices and the universally accepted standards for surgical sutures (e.g., USP monograph).

8. The sample size for the training set:

Not applicable. No "training set" in the context of machine learning or clinical trials is mentioned.

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

Not applicable. As above, no training set.

In summary: The provided document is a 510(k) premarket notification. These submissions demonstrate "substantial equivalence" of a new device to a legally marketed predicate device, rather than proving safety and effectiveness through new clinical studies with specific acceptance criteria that require extensive clinical data, sample sizes, and expert input as you might expect for a PMA or a novel device. The "study" here is primarily a comparison of the new device's characteristics and performance to established standards and the predicate device.

Summary

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K041894

Summary

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 CFR 807, this is to serve as a Summary of Safety and Effectiveness for the CP Medical absorbable seeding spacer product.

Manufacturer:	CP Medical, Inc.803 NE 25th AvenuePortland, OR 97232PHONE: (503) 232-1555FAX: (503) 230-9993
Contact Person:	Mary Ann Greenawalt, VPLegal & Regulatory Affairs
Device Name:

Trade Name:	Polyblend surgical suture
Common Name:	Nonabsorbable polyblend surgical suture
Proprietary name:	CP Fiber
Classification:	Class II; GAT

July 8, 2004 Date Prepared:

Predicate Device: The predicate device to the proposed CP Medical polyblend surgical suture, CP Fiber, is the existing CP Medical polyester surgical suture device. K001172 and Arthrex's FiberWIRE™ polyblend suture K010673, K021434.

Both predicate and proposed devices are indicated for use in soft tissue approximation; both meet USP for nonabsorbable sutures, may be siliconecoated or uncoated, and may be dyed or undyed with an appropriate FDA listed color additive. The sutures may also be provided with or without a standard needle attached.

Device Description:

The polyblend surgical suture meets USP requirements as described in the USP monograph for nonabsorbable surgical sutures.

CP Medical non-absorbable polyblend surgical sutures made with a braided, twisted core of polyethylene terephthalate and a polyethylene cover, are available in sterile form to an SAL of 106. Sterilization is performed by either Ethylene Oxide or Gamma Irradiation.

Indications for Use:

General soft tissue approximation including use in cardiovascular, ophthalmic, and neurological procedures. end

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image is a seal or logo featuring a stylized bird design. The bird is composed of three curved lines that suggest wings and a body. The seal is circular, with text arranged around the perimeter. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". The overall design is simple and symbolic, likely representing a government agency related to health and human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 7 2004

Ms. Mary Ann Greenawalt Vice President Legal & Regulatory CP Medical 803 NE 25th Avenue Portland, Oregon 97232

Re: K041894

Ro41071
Trade/Device Name: CP Fiber, Non-Absorbable Polyblend Surgical Suture Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable PET surgical suture Regulatory Class: II Product Code: GAT Dated: August 10, 2004 Received: August 18, 2004

Dear Ms. Greenwalt:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreas, 1976, the enactment date of the Medical Device Amendments, or to conniner of the to they 2011 - 11:25 accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Costiere Free (110.) that the device, subject to the general controls provisions of the Act. The r ou may, merelove, manes of the Act include requirements for annual registration, listing of general controls pro resuring 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 If your device is onastice (porace royals. Existing major regulations affecting your device can Inay be subject to satil additions, 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 I heast of advised that I Dr Pression that your device complies with other requirements of the Act that I DA has made a and regulations administered by other Federal agencies. You must of ally it cacial statutes and regaranents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set OI It rail 607), idoening (21 CFR Part 820); and if applicable, the electronic form in the quarty byetenis (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Mary Ann Greenawalt

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin manieting your antial equivalence of your device to a legally premarket notheation: "The PDF intellig of easification 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 If you desire specific advice for your ac 110 % 4659. Also, please note the regulation entitled, and Contact the Office of Complanes as (So t notification" (21CFR Part 807.97). You may obtain Misolanding of Terefore to premation on your responsibilities under the Act from the Division of Small other gelleral information on your responses at its toll-free number (800) 638-2041 or Manufacturers, Internet and Goless http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1_ of __ 1

510(k) Number (if known): K041894

CP Fiber, Non-Absorbable Polyblend Surgical Suture Device Name:

Indications for Use:

General soft tissue approximation including use in cardiovascular, ophthalmic and neurological procedures.

Please do not write below this line - continue on another page if necessary

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

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

510(k) Number K041894

Prescription Use

Over the Counter Use _________________________________________________________________________________________________________________________________________________________

(per 21 CFR 801.109)

Regulation Number and Section

§ 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.

(a)
Identification. Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed 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.