(58 days)
No
The description focuses on the mechanical operation of the device and does not mention any computational or learning components. The "automatically" action refers to a mechanical sequence, not an intelligent decision-making process. There is no mention of AI, ML, image processing, or data sets for training or testing algorithms.
No.
The device is described as a suturing device intended for tissue approximation and ligation during laparoscopic procedures, which is a surgical tool, not a therapeutic device.
No
Explanation: The device is described as a "Suturing Device" intended for "approximation and/or ligation of soft tissues in laparoscopic procedures." Its function is to deploy needles and sutures, which is a therapeutic action, not a diagnostic one.
No
The device description clearly outlines physical hardware components: a reusable Handle, a single-use disposable cartridge, and a suture. The performance studies also describe testing of the physical device and its components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "approximation and/or ligation of soft tissues in laparoscopic procedures." This describes a surgical tool used directly on the patient's body during a procedure.
- Device Description: The description details a mechanical device for placing sutures within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) during a surgical procedure.
N/A
Intended Use / Indications for Use
The NeatClose Suturing Device is intended for the approximation and/or ligation of soft tissues in laparoscopic procedures.
The NeatStitch NeatClose suturing device is intended for the approximation and/or ligation of soft tissues in laparoscopic procedures.
Product codes
HCF, GAM
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissues, inner abdominal wall
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon, laparoscopic procedures
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
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.
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.
The suture from the sterile and packed NeatClose Sutruing Device was tested for Sterility (USP general chapter 71), Tensile strength (USP 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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
ease of use, duration, safety and efficacy.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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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