(13 days)
The SuperStitch GW is indicated for use in performing vascular stitching in general wascular closure.
SuperStitch GW Models 06-15-04-GW; 08-15-04-GW
The provided text is a 510(k) summary for the Sutura, Inc.'s SuperStitch GW. This document primarily focuses on establishing substantial equivalence to a predicate device and obtaining regulatory clearance for market access. It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria as would typically be found in performance evaluation reports.
Therefore, many of the requested details, such as a table of acceptance criteria, reported device performance, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC study results, standalone performance, and ground truth establishment, are not available in the provided text.
The document indicates the following:
1. A table of acceptance criteria and the reported device performance
- Not available. The document is a 510(k) summary, which focuses on establishing substantial equivalence for regulatory clearance rather than presenting detailed performance study results against predefined acceptance criteria.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not available. No information about a specific test set or data provenance is provided.
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)
- Not available. No information about ground truth establishment or experts is provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not available. No information about adjudication methods is provided.
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 available. This device is a surgical suture delivery device, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a medical device (a suture delivery tool), not an algorithm or AI system. Therefore, the concept of "standalone algorithm performance" does not apply.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not available. The document does not describe performance studies that would require a defined ground truth.
8. The sample size for the training set
- Not available. The SuperStitch GW is a physical medical device, not an AI or machine learning algorithm that requires a training set in that context.
9. How the ground truth for the training set was established
- Not applicable. As a physical medical device, the concept of a "training set" with established ground truth is not relevant in the context of AI/ML models.
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DEC 2 7 2005
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510(k) SUMMARY
Sutura, Inc.'s SuperStitch GW
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Sutura, Inc. 17080 Newhope St. Fountain Valley, California 92708
(714) 437-9801 Phone: Facsimile: (714) 437-9806
Anthony Nobles Contact Person: December 14, 2005 Date Prepared:
Alternate Contact:
Gerard J. Prud'homme Hogan & Hartson L.L.P. 555 Thirteenth St. NW Washington D.C., 20004 Phone: (202) 637-5600
Name of Device and Name/Address of Sponsor
SuperStitch GW
Sutura, Inc. 17080 Newhope St. Fountain Valley, California 92708
Common or Usual Name
SuperStitch Guidewire Vascular Suture Delivery Device
Classification Name
Suture, Nonabsorbable, Synthetic, Polypropolene
Predicate Devices
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Image /page/1/Picture/0 description: The image shows handwritten text on a white background. The text on the first line reads "K053482". The text on the second line reads "page 2 of 2".
Sutura's SuperStitchVascular Suturing Device
Intended Use
The SuperStitch GW is indicated for use in performing vasular stitching in general
. All is and many min a many and a gain l. CW is not intended for The SuperStich GW is matcaled for about portschills. While and intended for blind vascular closure.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.
DEC 2 7 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Sutura, Inc. % Mr. Gerard J. Prud'Homme, Esquire Hogan & Hartson L.L.P. 555 13th Street, NW Washington, DC 20004
Re: K053482
Trade/Device Name: Superstich GW Models 06-15-04-GW; 08-15-04-GW Regulation Number: 21 CFR 878.5010 Regulation Name: Nonabsorbable polypropylene surgical suture Regulatory Class: II Product Code: GAW Dated: December 14, 2005 Received: December 14, 2005
Dear Mr. Prud'Homme:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bookshow on (t) personalially equivalent (for the indications for referenced above and have to legally marketed predicate devices marketed in interstate commerce use stated in the enoredure) to wgmant date of the Medical Device Amendments, or to devices that provision that 20, 1978, and cordance with the provisions of the Federal Food, Drug, and Cosmetic nave been rochassified and 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 therefore, mancer the detice, as joinements for annual registration, listing of devices, good vonufacturing 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 r your de fice is elasmod (tional controls. Existing major regulations affecting your device can be thay be subject to saon additions, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Eederal 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 r carates and regarments, 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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This letter will allow you to begin marketing your device as described in your Section 510(k) I mis icter will and w yours over finding of substantial equivalence of your device to a legally prematicated 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 rryou desire specific arreliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other INISULANDING OF Telection on your responsibilities under the Act from the Division of Small Manufacturers, general information on your Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Barbara Buchud
TN
Mark N. Melkerson Acting 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.
Indications for Use Statement
510(k) Number (if known): K053482
Device Name: SuperStitch Guide-wire Vascular Suture Delivery Device
Indications for Use:
The SuperStitch GW is indicated for use in performing vascular stitching in general wascular closure.
Prescription Use __X (Per 21 C.F.R. 801.109) OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER
) -- CONTINUE BACK CONTEMENT PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Barbara Muchard
Division of General, Restorative, and Neurological Devices
510(k) Number K053452
. DC 8016940002 - 2203578 v1
§ 878.5010 Nonabsorbable polypropylene surgical suture.
(a)
Identification. Nonabsorbable polypropylene surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene and is indicated for use in soft tissue approximation. The polypropylene surgical suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be undyed or dyed with an FDA approved color additive; and 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.