(86 days)
Not Found
No
The device description focuses on mechanical components and aspiration for tissue approximation and suturing, with no mention of AI or ML technologies. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
No
The device is described as a suturing device used for approximating soft tissue, which is a surgical tool, not a therapeutic device that directly treats a disease or condition.
No
The device description indicates its use for "approximation of soft tissue" and "place interrupted sutures into soft tissue," which are treatment-oriented actions, not diagnostic ones.
No
The device description clearly outlines a physical, sterile, single-use device with a handle, barrel, needle holder, needles, and suture material. It also requires a vacuum source connection. This is a hardware device, not software only.
Based on the provided information, the Edwards Lifesciences LifeStitch Suturing Device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for the approximation of soft tissue." This describes a surgical procedure performed directly on a patient's body.
- Device Description: The description details a mechanical device with needles and suture material used for physically joining tissue. This is consistent with a surgical instrument.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) outside of the body to provide information about a patient's health status, diagnose, monitor, or screen for diseases.
IVD devices are used in vitro (in glass, or outside the body) to analyze biological samples. The LifeStitch Suturing Device is used in vivo (in the body) during surgery.
N/A
Intended Use / Indications for Use
The Edwards Lifesciences LifeStitch Suturing Device is used for the approximation of soft tissue.
Product codes (comma separated list FDA assigned to the subject device)
GAT
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Functional/Safety Testing: The LifeStitch Suturing Device has successfully completed design verification testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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_