(53 days)
Not Found
No
The document describes a standard surgical suture and its physical properties and testing, with no mention of AI or ML.
No
This device is a surgical suture used for wound closure and other surgical procedures, which is a medical device but not classified as a therapeutic device. Therapeutic devices are typically those that administer therapy, such as drug delivery systems or devices for physical therapy.
No
Explanation: The device is a surgical suture used for wound closure and repairs, not for diagnosing conditions or diseases.
No
The device description clearly describes a physical surgical suture made of stainless steel, a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Description and Intended Use: The provided text clearly describes a surgical suture made of stainless steel. Its intended uses are for surgical procedures performed directly on the human body (abdominal wound closure, hernia repair, sternal closure, orthopedic procedures).
- Lack of In Vitro Testing: There is no mention of the device being used to test specimens outside of the body. The performance studies described are physical tests on the suture itself (diameter, length, tensile strength, needle attachment).
Therefore, based on the provided information, the Stainless Steel Surgical Suture is a surgical implant/device used in vivo during surgery, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
GAQ
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. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Abdomen, Hernia, Sternum, Orthopedic (including cerclage and tendon)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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.
1
| FEATURE | PREDICATE I | PREDICATE II | PROPOSED |
|---|---|---|---|
| Manufacturer | |||
| Indications for | |||
| Use: | Davis & Geck | ||
| Indicated for use in abdominal | |||
| wound closure, hernia repair, sternal | |||
| closure and certain orthopedic | |||
| procedures including cerclage and | |||
| tendon repair. | Ethicon | ||
| Indicated for use in abdominal | |||
| wound closure, hernia repair, | |||
| sternal closure and certain | |||
| orthopedic procedures including | |||
| cerclage and tendon repair. | CP Medical | ||
| Indicated for use in abdominal | |||
| wound closure, hernia repair, | |||
| sternal closure and certain | |||
| orthopedic procedures including | |||
| cerclage 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 suture | ||
| 302, 420 or 420F needles | 316L Stainless steel suture | ||
| 302, 420 or 420F needles | 316L stainless steel suture | ||
| 302, 420 or 420F needles | |||
| Product Code: | GAQ | GAQ | GAQ |
| - Number: | K955723 | K931271 | pending |
Substantial Equivalence/Comparison Da
I.
K030351
page 2/3
2
J. Device Description:
K030351
page 3/3
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
3
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.
4
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
5
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)
OF
Over-The-Counter Use
(Optional format 1-2-96)