(29 days)
The Abbott Vascular Suture Anastomosis Device is intended for use in the delivery of 10 interrupted sutures to assist the surgeon in the creation of vascular anastomoses.
The Abbott Vascular Suture Anastomosis Device is a hand-held surgical device that simultaneously deploys 10 lengths of 7-0 polypropylene suture at the site of a vascular anastomosis via a hydraulic delivery mechanism. The Abbott Vascular Suture Anastomosis Device is available in two models for creating either side-to-side or end-to-side anastomoses. After deployment of the device, the surgeon completes the anastomosis by hand-tying the appropriate surgical knots. Optional accessories available for use with the Abbott Vascular Suture Anastomosis (AVSA) Device include the Heartflo™ Scissors and the Heartflo™ Handle.
The Abbott Vascular Suture Anastomosis Device is a prescription device, restricted to use by physicians trained in vascular surgery.
The Abbott Vascular Suture Anastomosis Device is EtO sterilized and nonpyrogenic in an unopened undamaged package, for single use only.
The provided document is a 510(k) Premarket Notification for the Abbott Vascular Suture Anastomosis Device, not a study report. Therefore, it does not contain the detailed clinical study information typically found in such reports that would allow a comprehensive description of acceptance criteria and a study proving those criteria are met for diagnostic or AI-assisted devices.
This document describes a surgical device designed to assist surgeons in creating vascular anastomoses, not a diagnostic device or an AI-based system. The "acceptance criteria" and "study" described in the prompt are more relevant to validating the performance of diagnostic algorithms or AI systems, particularly in image interpretation or data analysis.
However, based on the information provided in the 510(k) summary (Section K. Device Description and F. Summary of Substantial Equivalence), I can address some aspects relevant to device validation, even if they don't perfectly align with the diagnostic AI-focused questions:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state quantitative "acceptance criteria" for performance metrics like sensitivity, specificity, or accuracy, which are typical for diagnostic devices. Instead, the "acceptance criteria" for this surgical device would be considered to be met if it demonstrates substantial equivalence to predicate devices in terms of its intended use, design, materials, and principle of operation, and if it is safe and effective.
The reported device performance is described through various tests in the "Summary of Substantial Equivalence." These are qualitative and assurance-based rather than quantitative performance metrics:
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility | Scientifically tested to ensure different materials are biocompatible. (Specific tests mentioned: Dermal Sensitization, Cytotoxicity, Intracutaneous Reactivity, Systemic Toxicity, Hemolysis) |
| Physical Properties Appropriateness for Intended Use | Scientifically tested to ensure physical properties are appropriate for intended use. (Specific test mentioned: Attachment strength of critical components) |
| Functionality and Reliability under Simulated/Actual Conditions | "Questions regarding the effects of any new technological characteristics... have been answered through accepted scientific methods. These methods assessed the new characteristics with regard to functionality and reliability under simulated and actual conditions of use."(Specific functional bench testing mentioned: suture deployment, suture spacing, suture management, tissue capture) |
| Safety and Effectiveness | Demonstrated through scientific tests, including in vivo animal testing. |
| Substantial Equivalence to Predicate Devices | "The Abbott Vascular Suture Anastomosis Device has been shown to be substantially equivalent to the Class II predicates on which the device is based." |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: The document does not specify a "test set sample size" in the context of diagnostic performance. For the in vivo animal testing, the number of animals used is not provided. For bench testing (suture deployment, spacing, etc.), the number of tests or samples is also not specified.
- Data Provenance: The tests mentioned are internal validation tests (biocompatibility, functional bench testing, in vivo animal testing) conducted by Perclose/Abbott Laboratories. The document does not specify the country of origin of the data beyond being generated by the applicant company. It implies these were specifically conducted for the device submission, making them prospective in nature relative to the submission.
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 to the type of device and validation described. "Ground truth" established by experts (e.g., radiologists) is relevant for diagnostic devices that interpret data (like images). For a surgical device, the validation focuses on its mechanical function, biocompatibility, and ability to perform its intended surgical action. The "ground truth" would be the successful deployment of sutures, proper anastomotic creation, and absence of adverse biological reactions, assessed by scientific and engineering methods, and potentially by veterinary surgeons in animal studies, but not "experts" in the sense of diagnostic interpretation.
4. Adjudication method for the test set:
Not applicable. Adjudication methods (like 2+1 or 3+1 consensus) are used to resolve discrepancies in expert interpretation for diagnostic ground truth establishment. This device's validation relies on objective physical, chemical, and biological testing, potentially observed and recorded by trained personnel, but not subject to multi-reader adjudication in the clinical diagnostic sense.
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 a surgical tool, not an AI-assisted diagnostic device. Therefore, no MRMC study for assessing human reader improvement with AI assistance would have been conducted or is relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a manual surgical tool that assists a human surgeon. It is not an algorithm and does not operate in a "standalone" fashion.
7. The type of ground truth used:
As mentioned, "ground truth" in the diagnostic sense is not directly applicable. For the various tests conducted:
- Biocompatibility: Ground truth is established by standardized biological tests (e.g., ISO 10993 series) and assessment of physiological responses.
- Functional Bench Testing: Ground truth is the successful and consistent operation of the mechanical features (e.g., correct suture deployment, spacing, tissue capture) according to design specifications and engineering measurements.
- Physical Properties: Ground truth is established by material testing standards (e.g., tensile strength, attachment strength).
- In vivo Animal Testing: Ground truth would be the successful creation of an anastomosis, tissue healing, and absence of complications, often assessed by veterinary observation, necropsy, and histological examination.
8. The sample size for the training set:
Not applicable. This is not an AI/machine learning device, so there is no concept of a "training set" for an algorithm.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for an algorithm.
{0}------------------------------------------------
K013683 (P.1 of 2)
Perclose, an Abbott Laboratories Co. Abbott Vascular SutureAnastomosis Device Special 510(k) Premarket Notification CONFIDENTIAL
DEC 0 6 2001
510(K) SUMMARY
| A. Sponsor/Submitter: | Perclose, an Abbott Laboratories Company400 Saginaw DriveRedwood City, CA 94063Tel: (650) 474-3000Fax: (650) 474-3020 |
|---|---|
| B. Contact Person: | Patty HeveyClinical Affairs Coordinator(650) 474-3202 |
| C. Date of Submission: | November 6, 2001 |
| D. Trade (Brand) Name: | Abbott Vascular Suture Anastomosis Device |
| E. Common Name: | Suture Delivery Device |
| F. Classification: | Class II |
| G. Classification Name: | Suture, Implantable |
| H. Product Code: | GAW |
| I. Predicate Devices: | 1. U.S. Surgical Corporation VCS Anastomotic Clip Cartridge, K9707932. Coalescent Surgical Sutured-Clip, K9941603. Deknatel (Genzyme Corporation) Deklene® II Surgical Suture |
J. Intended Use:
The Abbott Vascular Suture Anastomosis Device is intended for use in the delivery of 10 interrupted sutures to assist the surgeon in the creation of vascular anastomoses.
K. Device Description:
The Abbott Vascular Suture Anastomosis Device is a hand-held surgical device that simultaneously deploys 10 lengths of 7-0 polypropylene suture at the site of a vascular anastomosis via a hydraulic delivery mechanism. The Abbott Vascular Suture Anastomosis Device is available in two models for creating either side-to-side or end-to-side anastomoses. After deployment of
{1}------------------------------------------------
K013683 (P.2 of 2)
Perclose, an Abbott Laboratories Co. Abbott Vascular SutureAnastomosis Device Special 510(k) Premarket Notification CONFIDENTIAL
the device, the surgeon completes the anastomosis by hand-tying the appropriate surgical knots. Optional accessories available for use with the Abbott Vascular Suture Anastomosis (AVSA) Device include the Heartflo™ Scissors and the Heartflo™ Handle.
The Abbott Vascular Suture Anastomosis Device is a prescription device, restricted to use by physicians trained in vascular surgery.
The Abbott Vascular Suture Anastomosis Device is EtO sterilized and nonpyrogenic in an unopened undamaged package, for single use only.
F. Summary of Substantial Equivalence:
Perclose has submitted information on design, indications, materials, and principle of operation to establish that the Abbott Vascular Suture Anastomosis Device is substantially equivalent to currently marketed predicate devices.
The Abbott Vascular Suture Delivery Device has essentially the same intended use as the predicate devices. Questions regarding the effects of any new technological characteristics of the Abbott Vascular Suture Anastomosis Device have been answered through accepted scientific methods. These methods assessed the new characteristics with regard to functionality and reliability under simulated and actual conditions of use. Results of scientific testing have ensured that different materials are biocompatible and physical properties are appropriate for the intended use. Scientific tests conducted to ensure the safety and effectiveness of the Abbott Vascular Suture Anastomosis Device included:
- Dermal Sensitization .
- Cytotoxicity ●
- Intracutaneous Reactivity .
- Systemic Toxicity
- Hemolysis
- . Attachment strength of critical components
- Functional bench testing (e.g., suture deployment, suture spacing, suture . management, tissue capture)
- . In vivo animal testing
In conclusion, the Abbott Vascular Suture Anastomosis Device has been shown to be substantially equivalent to the Class II predicates on which the device is based.
{2}------------------------------------------------
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 0 6 2001
Perclose Ms. Patty Hevey Clinical Affairs Coordinator 400 Saginaw Drive Redwood City, California 94063
Re: K013683
Trade Name: Abbott Vascular Suture Anastomosis Device Regulation Number: 878.5010 Regulation Name: Polypropylene Suture Regulatory Class: II Product Code: GAW Dated: November 14, 2001 Received: November 15, 2001
Dear Ms. Hevey:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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.
{3}------------------------------------------------
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 premated predicated 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), 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). Other general information on your responsibilities under the Act may be obtained from the Ouvision 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 yours,
Susan Walker, MD
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
{4}------------------------------------------------
DEC 0 6 2001
Perclose, an Abbott Laboratories Co. Abbott Vascular Suture Anastomosis Device Special 510(k) Premarket Notification CONFIDENTIAL
INDICATIONS FOR USE STATEMENT
510(k) Number:
Device Name:
Abbott Vascular Suture Anastomosis Device
Indications for Use:
The Abbott Vascular Suture Anastomosis Device is indicated for use in the delivery of 10 interrupted sutures to assist the surgeon in the creation of vascular anastomoses.
Susan Wal
l
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K013683
§ 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.