(58 days)
The NeatClose Suturing Device is intended for the approximation and/or ligation of soft tissues in laparoscopic procedures.
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the access site through the port working channel (or without it), the needle guides are deployed and the device is withdrawn till the needle guides contact the inner abdominal wall.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
The provided text describes the NeatClose Suturing Device, a manual surgical instrument intended for approximation and/or ligation of soft tissues in laparoscopic procedures. The documentation focuses on demonstrating substantial equivalence to predicate devices and provides details about performance testing, including an animal study. However, it does not explicitly define acceptance criteria as a table of performance metrics with specific thresholds. Instead, it describes the conclusion of the study that the device is "effective, completely safe, reliable, fast and user-friendly."
Therefore, I will synthesize the information provided into the closest approximation of the requested table and then address the other points.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Feasibility | Demonstrate ability to be used for suturing in laparoscopic procedures | "Very effective" in the closure of port access in laparoscopic procedures. |
| Safety | No adverse events or unacceptable risks identified | "Completely safe" |
| Efficacy | Achieve successful tissue approximation and ligation comparable to existing methods. | "Very effective" in the closure of port access in laparoscopic procedures. Successfully performed suturing comparable to hand suturing and three other marketed devices. |
| Ease of Use | User-friendly operation | "User-friendly" |
| Speed/Duration | Comparable or improved speed of use | "Fast" |
| Reliability | Consistent performance | "Reliable" |
| Suture Characteristics (after sterilization and packaging) | Preservation of manufacturer's characteristics (degradation, tensile strength, diameter, needle attachment) and USP standards | Suture characteristics (tensile strength, diameter, needle attachment) preserved according to USP general chapters 71, 881, 861, and 871. |
| Sterility | Meet USP general chapter 71 standards | Tested and met USP general chapter 71 for sterility. |
| Sterilization Validation | Validated according to international standards | Sterilization validated per international standards. |
| Packaging and Shelf-life | Validation to be completed before commercial marketing | "In progress and will be completed before commercial marketing." (Implied acceptance is successful completion) |
2. Sample Size Used for the Test Set and the Data Provenance
- Test Set Sample Size: Two pigs were used for the comparative animal study, with 8 access sites in each pig (total of 16 access sites evaluated in the main comparative study). An additional pig was used later for an acute experiment focusing solely on the Neatstitch device in 6 access ports. So, a total of up to 3 pigs and 22 access sites were directly evaluated during the animal study.
- Data Provenance: The study was a prospective animal study conducted in a controlled environment, likely in Israel, given the sponsor's location (Or Akiva, Israel).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
The document does not explicitly state the number of experts or their qualifications for establishing ground truth in the animal study. The assessment of "ease of use, duration, safety and efficacy" was likely performed by the researchers/veterinarians conducting the study, who would be qualified in animal surgery and observation. However, specific numbers or detailed qualifications are not provided.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the animal study. It appears to be a direct observation and measurement study by the research team.
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
A Multi-reader Multi-case (MRMC) comparative effectiveness study was not conducted as this is a physical medical device (suturing device), not an AI-powered diagnostic or assistive tool for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
A standalone (algorithm-only) performance evaluation was not done as this is a physical medical device and does not involve an algorithm for standalone performance.
7. The Type of Ground Truth Used
The ground truth for the animal study was established through direct observation, comparative performance (against hand suturing and three other marketed devices), and measurement of parameters such as ease of use, duration, safety, and efficacy in a live biological system (pigs). Additionally, the ground truth for suture characteristics (tensile strength, diameter, needle attachment, sterility) was based on established USP general chapters and manufacturer-defined specifications.
8. The Sample Size for the Training Set
The concept of a "training set" is not applicable here as this is a physical medical device and not an AI/machine learning model. The animal study described serves as the primary "test set" for performance evaluation, not a training set.
9. How the Ground Truth for the Training Set was Established
As explained in point 8, the concept of a training set is not applicable to this device.
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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
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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
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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
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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.
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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
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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 |
§ 878.4493 Absorbable poly(glycolide/l-lactide) surgical suture.
(a)
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.(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.