(139 days)
Surgimatix ProxiFast Absorbable Staples are intended for use in abdominal, thoracic, gynecologic, orthopedic, plastic and reconstructive surgery for the subcuticular closure of skin with an approximate thickness of 1 to 5 mm where an absorbable tissue fastener is desired for temporary tissue approximation.
The device is not indicated for use in shallow or very small incisions, and is not indicated for final closure of the terminal 2 cm of incisions.
The ProxiFast Absorbable Staple is an absorbable staple for subcuticular skin closure. The staple is made of polydioxanone, and consists of a main body that is 19.35 mm in length, with an obround loop at either end, each of which measure 2.74 by 4.72 mm. The staple is formed into an s-shape the size of 10.3 mm x 17.3 mm prior to deployment, and forms a helical configuration when placed into the subcuticular skin. The Proxifast Absorbable staples are used in conjunction with a manual surgical stapler from Surgimatix, Inc. (Note: The Surgimatix manual surgical stapler is a Class I exempt device pursuant to 21 CFR 878.4800 and is not the subject of this submission).
The provided text describes a 510(k) summary for the ProxiFast™ Absorbable Staple, which sought to establish substantial equivalence to a predicate device. The information details the device's characteristics, indications for use, and performance data, but it does not include specific acceptance criteria for a device, nor does it detail a study designed to prove the device meets such criteria in the format requested.
The document primarily focuses on demonstrating substantial equivalence based on:
- Indications for Use: Comparing the intended use to the predicate device.
- Technological Characteristics: Highlighting similarities in material (both absorbable polymers with similar strength and absorption profiles), sterilization methods, and general physical attributes.
- Performance Data: General statements about mechanical, biocompatibility, and preclinical data.
There is no mention of a standalone algorithm or AI, multi-reader multi-case studies, ground truth establishment for a test set, or training set details as pertinent to AI/ML device evaluations. This document is for a physical medical device (an absorbable staple), not a diagnostic or AI-driven software device.
Therefore, for the specific questions regarding acceptance criteria and performance study details usually associated with diagnostic or AI/ML devices, the information is not present in this 510(k) summary.
However, extracting the information that is available about the "study" for this physical device, we can answer some aspects:
1. A table of acceptance criteria and the reported device performance
The submission does not explicitly state quantitative "acceptance criteria" for performance that can be presented in a table alongside reported device performance. Instead, it makes comparative statements relative to the predicate device regarding key performance aspects.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Perform as intended (functional performance) | Confirmed as performing as intended |
| No new issues of safety and effectiveness introduced | Confirmed no new issues of safety and effectiveness introduced |
| Usable for subcuticular closure in a range of skin thicknesses comparable to predicate | Demonstrated usability in a comparable range of skin thicknesses |
| Tensile strength comparable to the predicate device | Demonstrated comparable tensile strength after deployment |
| Biocompatible | Biocompatibility data confirmed |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "preclinical data, including a chronic animal study" and "functional and deployment testing in tissue," and "mechanical testing following deployment in tissue."
- Sample Size: Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The "chronic animal study" implies prospective data from an animal model. "Testing in tissue" could refer to ex-vivo or in-vivo human/animal tissue, but details are not 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)
This concept is not applicable to the performance data described for this physical device. The "ground truth" for a mechanical device is typically established through direct physical measurement and observation of its function, rather than expert interpretation of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This concept relates to human expert review of images or data, which is not described here.
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 is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For mechanical performance aspects, "ground truth" would be objective measurements (e.g., tensile strength, deployment characteristics) and observations in animal models for in-vivo performance (e.g., tissue approximation, absorption profile, chronic tissue response). Biocompatibility is based on standardized testing.
8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. There is no training set for this physical device.
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SECTION 5: 510(k) SUMMARY STATEMENT
This 510(k) summary is being submitted in accordance with the requirements of the Safe Medical Devices Act of 1990, 21 CFR 807.92
1. General Information
Date of Submission: August 26, 2013
| Submitted By: | Surgimatix, Inc. |
|---|---|
| 1539 Jarvis Street | |
| Elk Grove Village, IL 60007 |
Contact Person: Grace Carlson, MD Director, Regulatory and Clinical Affairs Phone 847-400-2546 Fax 847-258-3326 gcarlson@surgimatix.com
2. Trade/Proprietary Name of Device:
| Trade Name: | ProxiFast™ Absorbable Staple |
|---|---|
| Common Name: | Staple, Implantable |
| Regulation Number | 878.4750 |
| Product Code: | GDW |
| Device Panel: | General Surgery/Restorative Device |
| Device Classification: | Class II |
3. Legally Marketed Predicate Devices for Claimed Equivalence:
Name: INSORB Absorbable Staple 510(k) #: K090129
The Ethicon PDS™ Barbed Suture (K113004) is being referenced as a device made of polydioxanone. Therefore, the use of polydioxanone as a suture or fastener material is not new.
4. Device Description
The ProxiFast Absorbable Staple is an absorbable staple for subcuticular skin closure. The staple is made of polydioxanone, and consists of a main body that is 19.35 mm in length, with an obround loop at either end, each of which measure 2.74 by 4.72 mm. The staple is formed into an s-shape the size of 10.3 mm x 17.3 mm prior to deployment, and forms a helical configuration when placed into the subcuticular skin. The Proxifast Absorbable staples are used in conjunction with a manual surgical stapler from Surgimatix, Inc. (Note: The Surgimatix manual surgical stapler is a Class I exempt device pursuant to 21 CFR 878.4800 and is not the subject of this submission).
JAN 13 2014
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5. Indications for Use Statement
ProxiFast Absorbable Staples are intended for use in abdominal, thoracic, gynecologic, orthopedic, plastic and reconstructive surgery for the subcuticular closure of skin with an approximate thickness of 1 to 5 mm where an absorbable tissue fastener is desired for temporary tissue approximation.
The device is not indicated for use in shallow or very small incisions, and is not indicated for final closure of the terminal 2 cm of incisions.
6. Substantial Equivalence Comparison
Indications for Use
Substantial equivalence for the ProxiFast Absorbable Staple is supported by the predicate device listed in this submission, which has a similar indications statement. The Indications for Use Statement for the ProxiFast Absorbable Staple provides additional specificity with respect to the range of skin thicknesses for which the device is applicable compared to the predicate device.
Technological Characteristics
Key technological characteristics of the ProxiFast Absorbable Staple are similar to the predicate device:
The ProxiFast Absorbable Staple is manufactured from polydioxanone, whereas the predicate device is made from a polyglycolic/polylactic acid copolymer. Both polydioxanone and polyglycolic/polylactic acid copolymer are bioresorbable materials commonly used in the manufacture of absorbable surgical sutures. Both materials have similar strength profiles and comparable absorption time profiles.
The ProxiFast Absorbable Staple has a slightly different size and shape than the predicate device in its native configuration; however, once placed into the tissue, the size is roughly comparable.
The ProxiFast Absorbable Staple is a single use, sterile implantable device, sterilized by ethylene oxide. The predicate device is also a single use, sterile implantable device, sterilized by gamma irradiation. Both ethylene oxide and gamma irradiation are commonly used methods for the sterilization of implantable medical devices.
Performance Data
Mechanical, biocompatibility, and preclinical data, including a chronic animal study, confirmed that the ProxiFast Absorbable Staple performs as intended and that no new issues of safety and effectiveness are introduced. Functional and deployment testing in tissue demonstrated that the ProxiFast Absorbable Staple can be used for subcuticular closure in a range of skin thicknesses comparable to the predicate device. Mechanical testing following deployment in tissue
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K132669
demonstrated that the ProxiFast Absorbable Staple has a tensile strength comparable to the predicate device.
-
- Conclusion
The ProxiFast Absorbable Staple is substantially equivalent to the predicate device currently marketed in accordance with the Federal Food, Drug and Cosmetic Act.
- Conclusion
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Surgimatix Dr. Grace Carlson Director, Regulatory and Clinical Affairs 1539 Jarvis Avenue Elk Grove Village, Illinois 60007
January 13, 2014
Re: K132669
Trade/Device Name: Surgimatix ProxiFast Absorbable Staple Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: Class II Product Code: GDW Dated: December 12, 2013 Received: December 13, 2013
Dear Ms. Carlson:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 or any I with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Dr. Grace Carlson
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours, Joshua C. Nipper -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director For Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K132669
Device Name
. . . . . . . . .
Surgimatix ProxiFast Absorbable Staple
Indications for Use (Describe)
Surgimatix ProxiFast Absorbable Staples are intended for use in abdominal, thoracic, gynecologic, orthopedic, plastic and reconstructive surgery for the subcuticular closure of skin with an approximate thickness of I to 5 mm where an absorbable tissue fastener is desired for temporary tissue approximation.
The device is not indicated for use in shall incisions, and is not indicated for final closure of the terminal 2 cm of incisions.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
§ 878.4750 Implantable staple.
(a)
Identification. An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.