NEATSTITCH NEATCLOSE SUTURING DEVICE

K063462 · Neat Stitch , Ltd. · GAM · Jan 12, 2007 · General, Plastic Surgery

Device Facts

Record IDK063462
Device NameNEATSTITCH NEATCLOSE SUTURING DEVICE
ApplicantNeat Stitch , Ltd.
Product CodeGAM · General, Plastic Surgery
Decision DateJan 12, 2007
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 878.4493
Device ClassClass 2
AttributesTherapeutic

Intended Use

The NeatStitch NeatClose suturing device is intended for the approximation and/or ligation of soft tissues in laparoscopic procedures.

Device Story

NeatClose Suturing Device is a manual surgical instrument for laparoscopic soft tissue approximation/ligation. System consists of a reusable handle, single-use disposable cartridge containing needle guides and needles, and a pre-loaded suture. During use, the device is inserted through a port or access site; needle guides are deployed to contact the inner abdominal wall; needles are deployed to penetrate tissue and are retrieved into the cartridge; needle guides retract automatically. The device is then withdrawn, leaving the suture for the surgeon to tie manually. Used in clinical settings by surgeons. Benefits include efficient, reliable, and user-friendly port access closure compared to traditional hand suturing.

Clinical Evidence

Controlled animal study using two pigs (16 total access sites) compared the NeatClose device to hand suturing and three other marketed suturing devices. Evaluated feasibility, safety, efficacy, ease of use, and duration. Results concluded the device is effective, safe, reliable, and user-friendly for port access closure. Bench testing included USP-standardized validation for sterility (USP 71), tensile strength (USP 881), diameter (USP 861), and needle attachment (USP 871).

Technological Characteristics

Manual surgical instrument; reusable handle with single-use disposable cartridge. Pre-loaded with absorbable poly(glycolide/l-lactide) surgical suture. Operates via mechanical needle deployment and retrieval mechanism. Sterilization validated per international standards.

Indications for Use

Indicated for the approximation and/or ligation of soft tissues in laparoscopic procedures.

Regulatory Classification

Identification

An absorbable poly(glycolide/l-lactide) surgical suture (PGL suture) is an absorbable sterile, flexible strand as prepared and synthesized from homopolymers of glycolide and copolymers made from 90 percent glycolide and 10 percent l-lactide, and is indicated for use in soft tissue approximation. A PGL suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. “Monograph for Absorbable Surgical Sutures;” it may be monofilament or multifilament (braided) in form; it may be uncoated or coated; and it may be undyed or dyed with an FDA-approved 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

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ K063462 Pay NeatClose Suturing Device 11 Nov 2006 # 510(k) summary of Safety and Effectiveness NeatStitch Laparoscopic Closure device ### 1. Sponsor name NeatStitch Ltd. Hahadas 1 St. POB 132 Or Akiva Israel 30600 Tel: + 972 4 6262876 Fax: + 972 4 6262877 JAN 1 2 2007 #### 2. Device name Proprietary name: NeatClose Suturing Device Common/Usual name: Manual Surgical Instrument for general use. Classification name: Needle driver Class 1 (exempt) 878.4800 (Product code HCF- Instrument, Ligature Passing and Knot tying), Manual surgical instrument for general use Class II (510(k)) 878.4493 (Product code GAM- Suture, Absorbable, Synthetic polyclycolic acid) Absorbable poly(glycolide/l-lactide) surgical suture. # 3. Identification of Predicate or Legally marketed Device FASTCLOSE Suturing Device (K011105) LSI Solutions Suture Placement Device (K981531) ATRAMAT and SuperSorb Polyglycolic Acid Surgical Sutures (K040282). ### 4. Device description The NeatClose Suturing Device has three major component: 1) a reusable Handle, 2) a single-use disposable cartridge (containing a natented needle guides and needles), and 3) a suture. The cartridge (including the pre-loded suture) is assembled onto the Handle. The device is then inserted through the access site through the port working channel (or without it), the needle guides are deployed and the device is withdrawn till the needle guides contact the inner abdominal wall. Then the needles are deployed, penetrating the tissue and retrieved in the cartridge. Right after, automatically, the needle guides are retracted to the cartridge as well. Then the device is completely withdraws, leaving the suture to be tied by the surgeon as he/she routinely with {1}------------------------------------------------ K063462 NeatClose Suturing Device 11 Nov 2006 #### 5. Intended use The NeatClose Suturing Device is intended for the approximation and/or ligation of soft tissues in laparoscopic procedures. ## 6. Comparison of Technological Characteristics The NeatClose Suturing Device is substantially equivalent in intended use and/or function to the following predicate devices: FASTCLOSE Suturing Device (K011105), LSI Solutions Suture Placement Device (K981531), and the ATRAMAT and SuperSorb Polyglycolic Acid Surgical Sutures (K040282). The NeatClose Suturing Device is pre-loaded with a commercial cleared suture. The intended use of each of the predicate devices is soft tissue approximation and/or ligation of soft tissue. The NeatClose Suturing Device is used for the same intended use of soft tissue approximation and/or ligation as the predicate devices. The operating principle of the NeatClose Suturing Device is the same as that of the predicate devices: a manual instrument is used to pass needles through tissue for suturing. #### 7. Performance Testing The NeatClose Suturing Device performs the same function as a standard needle driver or guide. Since the NeatClose Suturing Device is pre-loaded with a non-sterile thread the suture was tested and showed that the suture characteristics as determined by the suture manufacturer (including degradation) and according to USP, are preserved after sterilization and packaging. In addition, prototype NeatClose Suturing Device was tested in a controlled animal study with two pigs (another pig was used later as an acute experiment with the use of only Neatstitch device in 6 access ports). The scope of this study was to evaluation the feasibility, casety, efficacy of the NeatClose Suturing Device with compared to hand suturing, and additional three currently marketed devices for suturing of the laparoscopic access site (none of them was one of the predicate devices of this notification). Two pigs were used for this comparison, with 8 access sites in each. The measurements were for ease of use, duration, safety and efficacy. It was concluded therefore that the NeatClose Suturing Device is a very effective, completely safe, reliable, fast and user-friendly device for the closure of port access in laparoscopic procedures. The suture from the sterile and packed NeatClose Sutruing Device was tested for Sterility (USP general chapter 71), Tensile strength (USP {2}------------------------------------------------ <063462 Page 3 NeatClose Suturing Device 11 Nov 2006 general chapter 881), Sutures-Diameter (USP general chapter 861) and Suture-Needle Attachment (USP general chapter 871). The sterilization was validated per international standards. Packaging and shelf-life validation are in progress and will be completed before commercial marketing. # Section 5. 510(k) Summary ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ {3}------------------------------------------------ Image /page/3/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 NeatStitch Ltd % Yossi Muncher, Ph.D. Vice President, Clinical and Regulatory Affairs Hahadas 1 ST. Or Akiva, Israel 30600 JAN 1 2 2007 Re: K063462 Trade/Device Name: NeatClose Suturing Device Regulation Number: 21 CFR 878.4493 Regulation Name: Absorbable poly(glycolide/L-lactide) surgical suture Regulatory Class: Class II Product Code: GAM, HCF Dated: November 11, 2006 Received: November 22, 2006 Dear Dr. Muncher: 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. Iisting 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. {4}------------------------------------------------ Page 2 Yossi Muncher, Ph.D. 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. 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), please contact the Office of Compliance at (240) 276-0115 Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Mark N. Melkersen Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ NeatClose Suturing Device 11 Nov 2006 510(k) number (if known): ____________________________________________________________________________________________________________________________________________________ Device name: NeatStitch NeatClose suturing Device Indication for use: The NeatStitch NeatClose suturing device is intended for the approximation and/or ligation of soft tissues in laparoscopic procedures. X Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) | (Division Sign-Off) | | |------------------------------------------------------------|---------| | Division of General, Restorative, and Neurological Devices | | | 510(k) Number | 1663462 | | Page 1 of | |
Innolitics
510(k) Summary
Decision Summary
Classification Order
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