← Product Code [GAT](/submissions/SU/subpart-e%E2%80%94surgical-devices/GAT) · K013990 # LIFESTITCH SUTURING DEVICE (K013990) _Edwards Lifesciences, LLC · GAT · Feb 27, 2002 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GAT/K013990 ## Device Facts - **Applicant:** Edwards Lifesciences, LLC - **Product Code:** [GAT](/submissions/SU/subpart-e%E2%80%94surgical-devices/GAT.md) - **Decision Date:** Feb 27, 2002 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.5000 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery - **Attributes:** Therapeutic ## Indications for Use The Edwards Lifesciences LifeStitch Suturing Device is used for the approximation of soft tissue. ## Device Story LifeStitch Suturing Device is a sterile, single-use instrument for approximating and placing interrupted sutures in soft tissue. Device features a handle/housing, 30F (10 mm) barrel (23 cm length), and a distal needle holder containing four stainless steel needles pre-attached with 4-0 nonabsorbable, monofilament polybutester suture. Operates via aspiration and mechanically activated needles; requires connection to an external vacuum source via provided tubing. Kit includes an optional knot pusher/cutter for lowering hand-tied knots and trimming tails. Used by clinicians in surgical settings to facilitate tissue approximation. ## Clinical Evidence Bench testing only; no clinical data provided. ## Technological Characteristics Sterile, single-use device. Materials include stainless steel needles and 4-0 nonabsorbable, monofilament polybutester suture. Features a 30F (10 mm) barrel, 23 cm length. Mechanical actuation via vacuum aspiration. No software or electronic components. ## Regulatory 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. ## Special Controls *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. ## Predicate Devices - Auto Suture™ ENDO STITCH™ Disposable Suturing Device ([K972911](/device/K972911.md)) - Sew-Right® SR•5™ Precision Remote Suturing Device ([K011016](/device/K011016.md)) - Novafil™ suture material ([K990952](/device/K990952.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ K013990 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 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. | | Indications for Use: | The LifeStitch Suturing Device is used for the approximation of
soft tissue. | | Comparative Analysis: | It has been demonstrated that the LifeStitch Suturing Device is
comparable to the predicate devices in design, intended use,
materials, and principle of operation. | | Functional/Safety Testing: | The LifeStitch Suturing Device has successfully completed
design verification testing. | | Conclusion: | The LifeStitch Suturing Device is substantially equivalent to
the predicate devices. | {1}------------------------------------------------ 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. {2}------------------------------------------------ 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 {3}------------------------------------------------ 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. (PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) 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_ --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GAT/K013990](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GAT/K013990) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com