Stainless Steel Surgical Suture is indicated for use in abdominal wound closure, hernia repair, sternal closure and certain orthopedic procedures including cerclage and tendon repair.

Device Description

The CP Medical Stainless Steel Surgical Suture, monofilament, manufactured by C.P. Medical is equivalent to Nonabsorbable Surgical Sutures, Monofilament Stainless Steel manufactured by: Davis-Geck US Surgical Danbury, CT 06810 and Ethicon, Inc. P O BOX 151 Somerville. NJ 08876-0151. C.P. Medical's proposed device is packaged as four (4) individual sutures inside one suture card. The four-unit suture card is placed into Tyvek and twelve Tyvek packs are inserted into a suture box. The suture may also be supplied in bulk on an OEM basis as requested via customer specifications. The suture is supplied sterile or non-sterile and is either Gamma Irradiated or EtO sterilized to the SAL of 10°. The shelf life/expiration date is validated to five years from date of manufacture. USP Size 5 (metric 7.0), 6 and 7 (length 18") are primarily intended to be used for sternal closures. Additional sizes and lengths may be available in the future. All product is tested to USP standards prior to market release. The proposed device meets the requirements of ASTM F138-00 Gr.2 (Reg. Melt).

AI/ML Overview

This summarization is for a 510(k) Premarket Notification for a Class II medical device, specifically a Stainless Steel Surgical Suture. These submissions primarily focus on demonstrating substantial equivalence to already legally marketed devices, rather than establishing de novo performance criteria against clinical outcomes.

Therefore, the requested information on acceptance criteria and a study proving the device meets them will be interpreted within the context of a 510(k) submission, meaning the "acceptance criteria" are typically USP standards and equivalence to predicate devices, and the "study" is often bench testing to confirm these standards are met.

Here's the breakdown:

Acceptance Criteria and Device Performance

Feature	Acceptance Criteria (Based on USP standards & Predicate Equivalence)	Reported Device Performance (CP Medical Stainless Steel Surgical Suture)
Indications for Use	Same as predicate devices (Davis & Geck, Ethicon): abdominal wound closure, hernia repair, sternal closure, certain orthopedic procedures (cerclage, tendon repair).	Indicated for use in abdominal wound closure, hernia repair, sternal closure and certain orthopedic procedures including cerclage and tendon repair.
Design	Same design as predicate devices.	Same.
Sterile	Same sterilization method as predicate devices, meeting SAL of 10⁻⁶.	Sterilized to SAL of 10⁻⁶ (Gamma Irradiated or EtO).
Sizes	USP Size 5, 6, 7.	USP Size 5, 6, 7 (length 18").
Material	316L Stainless steel suture, 302, 420 or 420F needles; meeting ASTM F138-00 Gr.2 (Reg. Melt).	316L stainless steel suture, 302, 420 or 420F needles; meets ASTM F138-00 Gr.2 (Reg. Melt).
Physical Properties	Meet or exceed current USP standards for suture diameter, suture length, straight pull tensile strength, and needle attachment strength.	All product tested to USP standards prior to market release; all sutures met or exceeded USP requirements.
Shelf Life	Validated to predicate shelf life or established through testing.	Validated to five years from date of manufacture.

Study Details to Prove Acceptance Criteria (Substantial Equivalence)

Sample sizes used for the test set and the data provenance:
- Test Set Description: The provided text indicates "Physical testing was performed on the predicate and proposed surgical sutures." While specific sample sizes for each test (suture diameter, length, tensile strength, needle attachment strength) are not explicitly stated, the implication is that sufficient samples were tested to demonstrate compliance with USP standards for each.
- Data Provenance: The testing was performed internally by CP Medical, Inc. or by a certified laboratory on their behalf, demonstrating compliance with USP standards. It appears to be prospective testing conducted for the purpose of this 510(k) submission. No country of origin for patient data is relevant as this is bench testing, not clinical data.
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. For a stainless steel surgical suture, "ground truth" is established by adherence to recognized regulatory standards (e.g., USP, ASTM) and physical test methods. There are no human experts "adjudicating" diagnostic or clinical "ground truth" in this context. The "truth" is whether the physical properties of the suture meet the predefined specifications.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. As this involves physical bench testing against objective standards, there is no need for expert adjudication methods like 2+1 or 3+1, which are common in clinical image interpretation studies. The results are quantitative measurements compared against a numerical threshold set by the USP.
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 device is a surgical suture, not a diagnostic imaging AI algorithm. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is entirely irrelevant to this submission.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable. This is a physical medical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this device's performance is objective, quantitative data obtained from physical and mechanical bench testing (e.g., measuring diameter, length, tensile strength, needle attachment strength) against established industry standards, specifically United States Pharmacopeia (USP) standards and ASTM F138-00 Gr.2.
The sample size for the training set:
- Not Applicable. This device is a physical product and does not involve AI or machine learning algorithms that require a "training set."
How the ground truth for the training set was established:
- Not Applicable. Since there is no training set, this question is not relevant.

Summary

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510 (k) Summary Report

Class II Special Controls Guidance Document, December 19, 2002

MAR 2 8 2003 KA30351

Establishment Name and Registration Number: A.

Establishment Name: CP MEDICAL, Inc. Registration: 3032563 Owner/Operator: 9034828

B. Applicant's Name and Address:

CP MEDICAL, Inc. 836 NE 24" Avenue Portland, Oregon 97232 Tel. 503-232-1555 Fax. 503-230-9993

C. Contact Person:

Mary Ann Greenawalt, VP Legal & Regulatory Affairs

Manufacturing Address: D.

CP MEDICAL, inc. 2414 NE Pacific Ave Portland, Oregon 97232 Tel. 503-232-1555 Fax. 503-230-9993

Device Name: E.

Classification Name: Stainless Steel Surgical Suture, non-Absorbable

Trade or Proprietary Name: TBD

Classification Information: F.

Device Class: I I General & Plastic Surgery Devices Panel Classification Panel: Product Code(s): GAQ

Performance/Recognized Standards: current USP standards G.

Labeling: See Appendix I for Packaging, Labeling, and Insert. H.

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FEATURE	PREDICATE I	PREDICATE II	PROPOSED
ManufacturerIndications forUse:	Davis & GeckIndicated for use in abdominalwound closure, hernia repair, sternalclosure and certain orthopedicprocedures including cerclage andtendon repair.	EthiconIndicated for use in abdominalwound closure, hernia repair,sternal closure and certainorthopedic procedures includingcerclage and tendon repair.	CP MedicalIndicated for use in abdominalwound closure, hernia repair,sternal closure and certainorthopedic procedures includingcerclage and tendon repair.
Design:	Same	Same	Same
Sterile:	Same	Same	Same
Coloring:	N/A	N/A	N/A
Sizes:	USP Size 5, 6, 7	USP 5, 6, 7	USP Size 5, 6, 7
Material:	316L Stainless steel suture302, 420 or 420F needles	316L Stainless steel suture302, 420 or 420F needles	316L stainless steel suture302, 420 or 420F needles
Product Code:	GAQ	GAQ	GAQ
- Number:	K955723	K931271	pending

Substantial Equivalence/Comparison Da

K030351
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J. Device Description:

K030351
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The CP Medical Stainless Steel Surgical Suture, monofilament, manufactured by C.P. Medical is equivalent to Nonabsorbable Surgical Sutures, Monofilament Stainless Steel manufactured by:

Davis-Geck US Surgical Danbury, CT 06810

Ethicon, Inc. P O BOX 151 Somerville. NJ 08876-0151

C.P. Medical's proposed device is packaged as four (4) individual sutures inside one suture card. The four-unit suture card is placed into Tyvek and twelve Tyvek packs are inserted into a suture box. See Packaging, Appendix I. The suture may also be supplied in bulk on an OEM basis as requested via customer specifications. The suture is supplied sterile or non-sterile and is either Gamma Irradiated or EtO sterilized to the SAL of 10°. See Appendix III. The shelf life/expiration date is validated to five years from date of manufacture.

Please see Appendix II for Supplier Certification and Specifications of the Stainless Steel Surgical Suture Material. The risk analysis method used by CP Medical is FMEA and fault tree analysis.

USP Size 5 (metric 7.0), 6 and 7 (length 18") are primarily intended to be used for sternal closures. Additional sizes and lengths may be available in the future. All product is tested to USP standards prior to market release. The proposed device meets the requirements of ASTM F138-00 Gr.2 (Reg. Melt). Physical testing was performed on the predicate and proposed surgical sutures, Testing was performed using methods described in current USP for suture diameter, suture length, straight pull tensile strength and needle attachment strength. All sutures met or exceeded USP requirements. See Technical Info. Appendix II.

end

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human profile, composed of flowing lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 8 2003

Ms. Mary Ann Greenawalt Vice President Legal and Regulatory Affairs CP Medical, Inc. 836 NE 24th Avenue Portland, Oregon 97232

Re: K030351

Trade/Device Name: Stainless Steel Surgical Suture Regulation Number: 21 CFR 878.4495 Regulation Name: Stainless steel suture Regulatory Class: II Product Code: GAQ Dated: January 31, 2003 Received: February 3, 2003

Dear Ms. Greenawalt:

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. Mary Ann Greenawalt

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 Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

uriam 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: K0306351

Device Name(s): Stainless Steel Surgical Suture

Indications for Use(s) of the Device:

Stainless Steel Surgical Suture is indicated for use in abdominal wound closure, hernia repair, sternal closure and certain orthopedic procedures including cerclage and tendon repair.

Please do not write below this line - continue on another page if necessary Concurrence of CDRH. Office of Device Evaluation (ODE)

uriam C. Provost

Division of General, Restorative and Neurological Device

510(k) Number K030351

Prescription Use X

(per 21 CFR 801.109)

Over-The-Counter Use

(Optional format 1-2-96)

Regulation Number and Section

§ 878.4495 Stainless steel suture.

(a)
Identification. A stainless steel suture is a needled or unneedled nonabsorbable surgical suture composed of 316L stainless steel, in USP sizes 12-0 through 10, or a substantially equivalent stainless steel suture, intended for use in abdominal wound closure, intestinal anastomosis, hernia repair, and sternal closure.(b)
Classification. Class II (special controls). The device, when it is a steel monofilament suture that is uncoated and does not incorporate barbs, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9. 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.