(86 days)
The Edwards Lifesciences LifeStitch Suturing Device is used for the approximation of soft tissue.
The Edwards LifeStitch Suturing Device is a sterile, single use only device that uses aspiration and mechanically activated surgical needles to approximate and place interrupted sutures into soft tissue. The LifeStitch suturing device has a handle/housing attached to a 30F (10 mm) barrel that is approximately 23 cm in length. Attached to the distal tip of the barrel is a needle holder that contains four stainless steel needles with pre-attached 4-0 nonabsorbable, monofilament polybutester surgical suture. Sterile tubing is provided for connection between the device and a vacuum source. The LifeStitch Suturing Device is provided in a kit that also contains an optional-use knot pusher/cutter for lowering hand-tied suture knots and cutting suture tails.
The Edwards LifeStitch Suturing Device (K013990) received 510(k) clearance based on substantial equivalence to predicate devices, rather than explicit acceptance criteria with specific performance metrics. Therefore, detailed acceptance criteria and a study demonstrating adherence using quantitative performance measures are not provided in the document.
The "Functional/Safety Testing" section states: "The LifeStitch Suturing Device has successfully completed design verification testing." However, the document does not elaborate on the specific tests conducted, their acceptance criteria, or the reported performance.
Here's an attempt to answer the questions based on the provided document, acknowledging the limitations due to the nature of a 510(k) summary focused on substantial equivalence:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Inferred from Substantial Equivalence Basis) | Reported Device Performance (Inferred from "Functional/Safety Testing") |
|---|---|
| Comparable design to predicate devices | Demonstrated through comparative analysis |
| Comparable intended use to predicate devices | Demonstrated through comparative analysis |
| Comparable materials to predicate devices | Demonstrated through comparative analysis |
| Comparable principle of operation to predicate devices | Demonstrated through comparative analysis |
| Safe for intended use (verified through design testing) | Successfully completed design verification testing |
| Effective for intended use (verified through design testing) | Successfully completed design verification testing |
Limitations: The document does not provide specific numerical or qualitative acceptance criteria (e.g., tensile strength, knot security, tissue approximation efficacy metrics) or the measured performance values.
2. Sample Size Used for the Test Set and Data Provenance:
The document does not provide details about a specific "test set" in the context of a clinical performance study with human subjects or a large-scale evaluation set for an algorithm. The "Functional/Safety Testing" likely refers to bench testing and potentially animal studies, but no sample sizes or data provenance (country, retrospective/prospective) are mentioned.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. The clearance is based on substantial equivalence to existing devices and design verification testing, not on an "AI algorithm" or a "test set" requiring expert ground truth in the way a diagnostic AI would.
However, the regulatory review process itself involves experts at the FDA.
4. Adjudication Method for the Test Set:
Not applicable for the reasons stated above.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not performed. This type of study is typically conducted for diagnostic devices, especially those incorporating AI, to assess the impact of the device on human reader performance. The LifeStitch Suturing Device is a surgical instrument.
6. Standalone (Algorithm Only) Performance Study:
No, a standalone performance study in the context of an algorithm's performance was not done. The LifeStitch Suturing Device is a physical medical device for suturing, not an algorithm.
7. Type of Ground Truth Used:
The "ground truth" for the device's substantial equivalence and safety/effectiveness is established through:
- Comparison to predicate devices: The established safety and effectiveness of the existing predicate devices (Auto Suture ENDO STITCH, Sew-Right SR•5, Novafil™ suture material) serve as a de facto "ground truth" for the new device's comparable attributes.
- Design verification testing: This would involve engineering specifications, material testing, functional testing (e.g., ability to place sutures, tension, knot security), and potentially biocompatibility tests to ensure the device meets predefined performance and safety criteria.
8. Sample Size for the Training Set:
Not applicable. This device is not an AI algorithm and therefore does not have a "training set" in the machine learning sense.
9. How the Ground Truth for the Training Set Was Established:
Not applicable for the reasons stated above.
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Image /page/0/Picture/1 description: The image shows a logo with a large, stylized letter 'E' as its central element. The 'E' is white and stands out against a background of black squares arranged in a grid pattern. Overlapping the 'E' are several white circles of varying sizes, creating a sense of depth and complexity. Below the graphic is the word 'Edwards' in a simple, sans-serif font.
Edwards
FEB 2 7 2002
510(k) Summary
| Submitter: | Edwards Lifesciences LLC |
|---|---|
| Contact Person: | Lucinda Stockert, Regulatory Associate |
| Date Prepared: | February 14, 2000 |
| Trade name: | LifeStitch Suturing Device |
| Classification name: | Nonabsorbable poly(ethylene terephthalate) surgical suture |
| Predicate Devices: | • Auto Suture™ ENDO STITCH™ Disposable Suturing Device (K972911)• Sew-Right® SR•5™ Precision Remote Suturing Device (K011016)• Novafil™ suture material (K990952) |
| Device Description: | The Edwards LifeStitch Suturing Device is a sterile, single useonly device that uses aspiration and mechanically activatedsurgical needles to approximate and place interrupted suturesinto soft tissue. The LifeStitch suturing device has ahandle/housing attached to a 30F (10 mm) barrel that isapproximately 23 cm in length. Attached to the distal tip of thebarrel is a needle holder that contains four stainless steelneedles with pre-attached 4-0 nonabsorbable, monofilamentpolybutester surgical suture. Sterile tubing is provided forconnection between the device and a vacuum source. TheLifeStitch Suturing Device is provided in a kit that alsocontains an optional-use knot pusher/cutter for lowering hand-tied suture knots and cutting suture tails. |
| Indications for Use: | The LifeStitch Suturing Device is used for the approximation ofsoft tissue. |
| Comparative Analysis: | It has been demonstrated that the LifeStitch Suturing Device iscomparable to the predicate devices in design, intended use,materials, and principle of operation. |
| Functional/Safety Testing: | The LifeStitch Suturing Device has successfully completeddesign verification testing. |
| Conclusion: | The LifeStitch Suturing Device is substantially equivalent tothe predicate devices. |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 7 2002
Ms. Lucinda Stockert Regulatory Affairs Associate Edwards Lifesciences LLC One Edwards Way Irvine, California 92614
Re: K013990
Trade/Device Name: LifeStitch Suturing Device Regulation Number: 878.5000 Regulation Name: Nonabsorbable poly(ethylene terephthalate) surgical suture Regulatory Class: II Product Code: GAT Dated: November 30, 2001 Received: December 3, 2001
Dear Ms. Stockert:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use sured in the encreated of to the enactment date of the Medical Device Amendments, or to conninered prices that have been reclassified in accordance with the provisions of the Federal Food, DNI, a de necs that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The Tou may, dicierore, market 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 If your device is classified (600 above) and existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations a FR may be subject to back academans, 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 I lease of devices that I Dr ination that your device complies with other requirements of the Act that I Dr Has Intact a and regulations administered by other Federal agencies. You must or any I catal statutes and regulaments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set OI It I art 607), idoling (21 CFR Part 820); and if applicable, the electronic form in the quality by sections (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Ms. Lucinda Stockert
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 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 Division 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,
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
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Page__________________________________________________________________________________________________________________________________________________________________________ of
510(k) Number K013990:
LifeStitch Suturing Device Device Name:
Indications for Use:
The Edwards Lifesciences LifeStitch Suturing Device is used for the approximation of soft tissue.
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Concurrence of CDRH, Office Of Device Evaluation (ODE)
OR
Prescription Use (Per 21 CFR 801.109)
Over-The-Counter Use
for Muke N Mellems
Division Sign-Off
vision Sign-Off) General, Restorative ivision of and Neurological Devices 510(k) Number -
10(k) Number_
§ 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.
(a)
Identification. Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed 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.