(55 days)
CP Medical's synthetic absorbable monofilament is indicated for use in soft tissue approximation and/or ligation but not for use in cardiovascular or neurological surgery, microsurgery or ophthalmic surgery.
MonoSwift™ is intended to be used for surgical wound closure.
The proposed device is a synthetic absorbable monofilament surgical suture comprised of polydioxanone, trimethylene-carbonate and caprolactone copolymers. These polymers, individually, and as co-formulated herein, are substantially equivalent to other synthetic absorbable monofilament sutures in commercial distribution today.
The provided text is a 510(k) premarket notification summary for a medical device (surgical suture). It primarily focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and the comprehensive study that proves the device meets those criteria in a typical "AI/software device" context.
Therefore, many of the requested sections below cannot be fully answered with the information provided because this document is for a physical surgical suture, not an AI or software-based medical device. The "study" mentioned is conformity to recognized consensus standards for surgical sutures, which is different from a performance study for AI.
Here's an analysis based on the available information:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (for surgical sutures) | Reported Device Performance |
|---|---|
| Meets recognized consensus standards for surgical suture, United States Pharmacopoeia (USP) | Device meets these standards. |
| Meets ISO 10993 biocompatibility | Device meets these standards. |
| Similar characteristics (chemistry, material, and composition) to predicate devices | The device has similar characteristics as the predicate devices. |
| Manufacturing in compliance with current QSR and ISO quality standards | Manufacturing, including QC testing, is in substantial compliance with current QSR and ISO quality standards. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in the provided text.
- Data Provenance: Not specified, but given it's a physical product, the testing would likely be performed in a lab setting rather than using "data provenance" in the sense of patient data from specific countries.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not applicable and not provided. "Ground truth" in the context of material science and biocompatibility testing for a surgical suture refers to established scientific/medical standards (USP, ISO) rather than expert consensus on interpretive data as in AI.
4. Adjudication method for the test set
- Not applicable and not provided. Adjudication methods like 2+1 or 3+1 are typically for human interpretation tasks, not physical material testing.
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 device is a surgical suture, not an AI or imaging diagnostic device that would 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 device is a surgical suture, not an algorithm.
7. The type of ground truth used
- The "ground truth" for evaluating this device's safety and effectiveness relies on adherence to recognized consensus standards, specifically:
- United States Pharmacopoeia (USP) for surgical suture specifications.
- ISO 10993 for biocompatibility.
- The primary "proof" for this 510(k) submission is also substantial equivalence to an existing legally marketed predicate device (CP Medical's polydioxanone surgical suture) based on its chemistry, material, and composition.
8. The sample size for the training set
- Not applicable. This device is a physical product the subject of material science and manufacturing standards, not an AI model that requires a "training set."
9. How the ground truth for the training set was established
- Not applicable. See point 8.
{0}------------------------------------------------
K03 0786
MAY 0 6 2003
SAFETY AND EFFECTIVENESS 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 Volume 21 of the Code of Federal Regulations, this is to serve as a Summary of Safety and Effectiveness for the proposed CP Medical synthetic absorbable monofilament surgical suture.
| Manufacturer: | CP Medical, Inc.836 NE 24th AvenuePortland, OR 97232Phone: 503-232-1555FAX: 503-230-9993 |
|---|---|
| Contact Person: | Mary Ann Greenawalt, VP Legal & Regulatory Affairs |
| Device Name:Classification: | MonoSwift™ - synthetic absorbable monofilament sutureClass II |
| Date Prepared: | March 5, 2003 |
| Device Description: | The proposed device is a synthetic absorbable monofilament surgicalsuture comprised of polydioxanone, trimethylene-carbonate andcaprolactone copolymers. These polymers, individually, and as co-formulated herein, are substantially equivalent to other syntheticabsorbable monofilament sutures in commercial distribution today. |
| Predicate Devices: | The proposed device is substantially equivalent to CP Medical'spolydioxanone surgical suture and is similar in absorption rates to CPMedical's collagen suture material. |
| Indications: | MonoSwift™ is indicated for use in soft tissue approximation and/orligation but not for use in cardiovascular or neurological surgery,microsurgery or ophthalmic surgery. |
| Intended Use: | MonoSwift™ is intended to be used for surgical wound closure. |
| Summary of Clinical and Non-Clinical Studies: | Meets recognized consensus standards for surgical suture, United StatesPharmacopoeia and ISO 10993 biocompatibility. |
| Comparison of Technological Characteristics: | The device has similar characteristics (chemistry, material andcomposition) as the predicate devices. Manufacture of this device,including QC testing, is in substantial compliance with current QSR andISO quality standards. |
end
{1}------------------------------------------------
Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services USA. The seal is circular with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged around the top half of the circle. Inside the circle is an abstract image of an eagle with three human profiles incorporated into its design. The eagle's head and body are formed by the silhouettes of the human faces.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Mary Ann Greenawalt Vice President, Legal and Regulatory Affairs CP Medical, Inc. 836 NE 24th Avenue Portland, Oregon 97232
MAY 0 6 2003
Re: K030786
Trade/Device Name: Monofilament-Synthetic Absorbable Monofilament Surgical Suture Regulation Number: 21 CFR 878.4840 Regulation Name: Absorbable Polydioxanone Surgical Suture Regulatory Class: II Product Code: NEW Dated: March 10, 2003 Received: March 12, 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. Iisting 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.
{2}------------------------------------------------
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, v 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 yours,
Miriam C. Provost
tol 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
{3}------------------------------------------------
INDICATIONS FOR USE
Page 1 of 1
510(k) (if known):
DEVICE Name: Monofilament -Synthetic Absorbable Monofilament Surgical Suture
Indications for Use:
CP Medical's synthetic absorbable monofilament is indicated for use in soft tissue approximation and/or ligation but not for use in cardiovascular or neurological surgery, microsurgery or ophthalmic surgery.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use the image is of a form with the following content:
| Labels | Values |
|---|---|
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
| Prescription Use | |
| OR | |
| Over-the-Counter Use | |
| (Optional Format 1-2-96) |
Muriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K030786
§ 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.