(56 days)
Monoswift™ is a monofilament, synthetic absorbable suture 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 a monofilament, synthetic absorbable suture indicated for use in soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological surgery, microsurgery, or ophthalmic surgery.
This looks like a 510(k) summary for a medical device (Monoswift™ Synthetic Absorbable Suture), which is a premarket submission made to the FDA to demonstrate that the device is at least as safe and effective as a legally marketed predicate device.
The provided document does not contain the kind of detailed study information (like sample sizes, expert qualifications, adjudication methods, or MRMC studies) that would be present for evaluating a diagnostic AI/ML device. The document primarily focuses on demonstrating substantial equivalence to predicate devices based on design verification and USP requirements for needle attachment tensile strength.
Therefore, for this specific input, the requested information cannot be fully provided because it pertains to a different type of device evaluation (e.g., for AI/ML diagnostic software) than what is presented here.
However, I can extract the relevant information that is present in the document.
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with USP requirements for needle attachment tensile strength. | "The testing and verification activities performed for this product demonstrate that the product complies with USP requirements for needle attachment tensile strength." |
| Breaking strength retention consistent with predicate PGCL sutures. | "Breaking strength retention is consistent with the predicate PGCL sutures." |
| Overall performance similar to other PGCL sutures (monofilament, synthetic, absorbable, comprised of poly(glycolic co-caprolactone), may be dyed with D&C Violet #2). | "Monoswift™ performance for the intended use is similar to that of other PGCL sutures in that it is a monofilament, synthetic absorbable surgical suture comprised of poly(glycolic co-caprolactone) and may be dyed with D&C Violet #2." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size for Test Set: Not specified in the provided document.
- Data Provenance: Not specified in the provided document. The manufacturer is CP Medical, Portland, OR, USA. The testing was likely conducted in the US.
- Retrospective or Prospective: Not specified.
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):
- This information is not applicable and not present for this type of device (surgical suture). Ground truth in the context of diagnostic AI/ML refers to diagnoses or classifications established by human experts or definitive tests. For a surgical suture, the "ground truth" relates to its physical and biological performance characteristics, measured through various laboratory and potentially in-vivo tests, rather than expert interpretation of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable and not present for this type of device. Adjudication methods are relevant for resolving discrepancies in expert interpretations in diagnostic studies.
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. MRMC studies are used to evaluate the performance of diagnostic imaging devices (often with AI assistance). This device is a surgical suture.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is not an algorithm-only device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For this device, the "ground truth" or reference standard for verification is based on USP (United States Pharmacopeia) requirements for needle attachment tensile strength and comparison of breaking strength retention with predicate devices. This involves laboratory testing and performance metrics of the suture material itself, rather than expert interpretation of patient data or outcomes in the traditional sense of diagnostic devices.
8. The sample size for the training set:
- Not applicable. This device does not use a training set in the context of machine learning.
9. How the ground truth for the training set was established:
- Not applicable. This device does not use a training set.
In summary, the provided document outlines a 510(k) submission for a surgical suture, where "acceptance criteria" are related to physical and performance characteristics of the material (e.g., tensile strength, absorbability) as measured against established standards (like USP) and comparison to predicate devices, rather than the diagnostic performance metrics typically associated with AI/ML devices.
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K072229 LL
Image /page/0/Picture/1 description: The image shows the logo for CPI Medical. The logo has the letters CPI in a stylized font, with the letters outlined in white and filled with a gray pattern. The word "Medical" is written in a similar font to the right of the letters CPI. Below the logo, the words "Portland, OR USA" are written in a smaller font.
OCT 5" 2007
510(k) SUMMARY OF SAFETY & EFFECTIVENESS
| Device Name: | Monoswift™ Synthetic Absorbable Suture |
|---|---|
| Device Model Number: | "Lxxx" series |
| Classification Name: | Absorbable Suture, Synthetic, Polyglycolic Acid (GAM) |
| Device Classification: | Class II, 21 CFR 878.4493 |
| Predicate Devices: | CP Medical Visorb, K002190Ethicon Monocryl, K960053 (dyed) , K964072 (undyed) |
| Manufacturer: | CP Medical803 NE 25th Ave.Portland, OR 97232 USA |
| EstablishmentRegistration Number: | 3032563 |
| Official Contact: | Betsy CortelloniRegulatory Affairs ManagerTheragenics Corporation®5203 Bristol Industrial WayBuford, GA 30518Phone: 770-271-0233Fax: 770-831-4369 |
Intended Use: Monoswift™ is a monofilament, synthetic absorbable suture indicated for use in soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological surgery, microsurgery, or ophthalmic surgery.
Device Description: Monoswift™ is a monofilament, synthetic absorbable suture indicated for use in soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological surgery, microsurgery, or ophthalmic surgery.
Substantial Equivalence Comparison: Monoswift™ performance for the intended use is similar to that of other PGCL sutures in that it is a monofilament, synthetic absorbable surgical suture comprised of poly(glycolic co-caprolactone) and may be dyed with D&C Violet #2. Breaking strength retention is consistent with the predicate PGCL sutures.
Design Verification: The testing and verification activities performed for this product demonstrate that the product complies with USP requirements for needle attachment tensile strength.
Conclusion: The results of verification testing confirmed that design inputs were achieved and that Monoswift™ is substantial equivalent to the predicate devices.
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Image /page/1/Picture/1 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's emblem, which is a stylized caduceus, a symbol often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the emblem in a circular fashion.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
CP Medical % Theragenics Corporation Ms. Betsy Cortelloni Regulatory Affairs Manager 5203 Bristol Industrial Way Buford, Georgia 30518
OCT 5 2007
Re: K072229
Trade/Device Name: Monoswift" Synthetic Absorbable Suture Regulation Number: 21 CFR 878.4493 Regulation Name: Absorbable poly (glycolide/L-lactide) surgical suture Regulatory Class: II Product Code: GAM Dated: August 9, 2007 Received: August 10, 2007
Dear Ms. Cortelloni:
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
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Page 2 - Ms. Betsy Cortelloni
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. 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 (240) 276-0115. 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 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 yours,
Mark A. Milliken
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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cc: HFZ-401 DMC HFZ-404 510(k) Staff
HFZ-410 Division D.O. f/t:NOH:kxl:10-03-07
OC Numbers:
| Division of Enforcement A | 240-276-0115 |
|---|---|
| Dental, ENT and Ophthalmic Devices Branch | 240-276-0115 |
| OB/GYN, Gastro. & Urology Devices Branch | 240-276-0115 |
| General Hospital Devices Branch | 240-276-0115 |
| General Surgery Devices Branch | 240-276-0115 |
| Division of Enforcement B | 240-276-0120 |
| Cardiovascular & Neurological Devices Branch | 240-276-0120 |
| Orthopedic, Physical Medicine & Anesthesiology Devices Br | 240-276-0120 |
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INDICATIONS FOR USE FORM
510(K) number (if known):_____________________________________________________________________________________________________________________________________________________ K072229
Device Name: MonoSwift™
Indications for Use:
Monoswift™ is a monofilament, synthetic absorbable suture indicated for use in soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological surgery, microsurgery, or ophthalmic surgery.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Murla A. Wilkerson
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
Page 1 of 1
510(k) Number
§ 878.4493 Absorbable poly(glycolide/l-lactide) surgical suture.
(a)
Identification. An absorbable poly(glycolide/l-lactide) surgical suture (PGL suture) is an absorbable sterile, flexible strand as prepared and synthesized from homopolymers of glycolide and copolymers made from 90 percent glycolide and 10 percent l-lactide, and is indicated for use in soft tissue approximation. A PGL suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. “Monograph for Absorbable Surgical Sutures;” it may be monofilament or multifilament (braided) in form; it may be uncoated or coated; and it may be undyed or dyed with an FDA-approved 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.