This procedure kit is intended to facilitate passage of suture through the soft tissues of the body during laparoscopic surgery. It is to be used only by surgeons trained in laparoscopic surgery.

Device Description

The components of the Mctra PS Procedure Kit are One needle point suture passer, one grasper, one knot pusher/ positioning device, suture matcrial, and two suture guides.

AI/ML Overview

This document is a 510(k) premarket notification for the Inlet Medical Inc. Metra Positioning System (PS) Procedure Kit. It claims substantial equivalence to a predicate device and does not involve AI or complex software. As such, the specific information requested in your prompt (acceptance criteria, study details, sample sizes, ground truth, expert involvement, MRMC studies, standalone performance, training set details) is not applicable to this type of medical device submission.

Here's why and what information can be extracted:

Not Applicable Sections & Why:

Acceptance Criteria & Reported Device Performance Table: This device is a manual surgical instrument. Its "performance" is primarily related to its mechanical function, material compatibility, and similarity to a known predicate. There are no quantifiable performance metrics like sensitivity, specificity, accuracy, or F1-score typically associated with AI/software devices. Equivalence is based on design and intended use.
Sample size for the test set and data provenance: No test set in the AI/software sense exists. Evaluation for such devices typically involves design verification, manufacturing controls, and comparison to a predicate.
Number of experts used to establish the ground truth for the test set and qualifications: Ground truth, in the context of AI, refers to expert labeling or definitive diagnoses. This is not relevant for a manual surgical instrument.
Adjudication method for the test set: Not applicable.
Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable, as there is no AI component to measure human improvement with or without.
Standalone (i.e., algorithm only without human-in-the-loop performance) study: Not applicable, as this is a manual instrument requiring human operation.
Type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
Sample size for the training set: Not applicable, as there is no AI algorithm to train.
How the ground truth for the training set was established: Not applicable.

What can be extracted/inferred from the document regarding "acceptance" and "study":

Acceptance Criteria (Implicit - Substantial Equivalence): The primary "acceptance criteria" for this 510(k) submission is demonstrating substantial equivalence to a predicate device already legally marketed in the US. This means showing that the new device is as safe and effective as the predicate.
- Key aspects of substantial equivalence are:
  - Same intended use.
  - Similar technological characteristics (design, materials, operating principles).
  - Any differences do not raise new questions of safety or effectiveness.
Reported Device Performance (Implicit - Similarity to Predicate):
- Intended Use: "To facilitate passage of suture through the soft tissues of the body during laparoscopic surgery." (Identical to predicate)
- Design/Technological Characteristics: "The Inlet Medical Inc. disposable Metra PS Procedure Kit is substantially equivalent to the Needle-Point Suture Passer Instruments Set. Both the Metra PS Procedure Kit and the predicate device, Needle Point Suture Passer Instrument Sct (K980123), are similar in design. The predicate device consists of a Needle Point Suture Passer and 2 suture guides." The new kit adds a grasper, knot pusher/positioning device, and suture material for convenience, which are considered non-significant differences that do not alter the fundamental safety or effectiveness of the suture passing function.
The "Study" (Comparison to Predicate):
- The "study" in this context is a comparison of technological characteristics and intended use between the new device and the predicate device, as presented in Section 6 of the submission. The FDA reviews this comparison to determine substantial equivalence.

Summary based on the provided document:

Criteria/Aspect	Description/Finding
Acceptance Criteria	Demonstration of Substantial Equivalence to a Predicate Device. This involves showing: - Same intended use. - Similar technological characteristics (design, materials, operating principles). - Any differences do not raise new questions of safety or effectiveness.
Reported Device Performance	The device's "performance" is deemed substantially equivalent to the predicate device, the Inlet Medical Needle Point Suture Passer Instrument Set (K980123). Both are intended to facilitate suture passage during laparoscopic surgery and are similar in design. The additional components in the Metra PS Procedure Kit (grasper, knot pusher/positioning device, suture material) are for convenience and do not alter the core function or safety/effectiveness of the suture passing mechanism compared to the predicate's core components.
Sample Size (Test Set)	Not applicable (no test set in the context of AI/software performance evaluation). This is a manual surgical instrument.
Data Provenance	Not applicable.
Number of Experts (Ground Truth)	Not applicable.
Qualifications of Experts	Not applicable.
Adjudication Method	Not applicable.
MRMC Comparative Effectiveness	Not applicable (no AI component).
Standalone Performance	Not applicable (manual instrument, not an algorithm).
Type of Ground Truth	Not applicable.
Sample Size (Training Set)	Not applicable (no AI component or training set).
Ground Truth for Training Set	Not applicable.

Summary

{0}------------------------------------------------

K984600

3 1338 JUN

Inlet Medical Inc. Metra Positioning System (PS) Procedure Kit

Name and Address 1.

Inlet Medical Inc. 10180 Viking Drive Eden Prairie, MN 55344 Telephone (612) 942-5034 Facsimile: (612)-829-7112

Contact Person - Bob Gabler

Date of summary preparation - May 19, 1999

2. Device Name

Proprietary Name: Common/Usual Name: Classification Name:

Metra Positioning System (PS) Procedure Kit Metra PS Procedure Kit Manual Surgical Instrument for General Use

3. Identification of the predicate or legally marketed device(s) to which equivalence is being claimed

The Inlet Medical Mctra PS Procedure Kit is substantially equivalent to the Inlet Medical Needle Point Suture Passer Instrument Sct (K980123).

4. Device Description

The components of the Mctra PS Procedure Kit are One needle point suture passer, one grasper, one knot pusher/ positioning device, suture matcrial, and two suture guides.

5. Intended Use

This procedure kit is intended to facilitate passage of suture through the soft tissues of the body during laparoscopic surgery. It is to be used only by surgeons trained in laparoscopic surgery.

{1}------------------------------------------------

6. A statement of how the technological characteristics of the device compare to those of the predicate of legally marketed device(s) cited.

The Inlet Medical Inc. disposable Metra PS Procedure Kit is substantially equivalent to the Needle-Point Suture Passer Instruments Set. Both the Metra PS Procedure Kit and the predicate device, Needle Point Suture Passer Instrument Sct (K980123), are similar in design. The predicate device consists of a Needle Point Suture Passer and 2 suture guides. They both are used to facilitate passage of suture through the soft tissues of the body during laparoscopic surgery. The knot pusher/positioning instrument and the suture material (P840041) are being packaged in the Metra PS Procedure Kit for convenience.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle or bird-like figure, composed of three curved lines that suggest the shape of a bird in flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 3 1559

Mr. Mark Sterrett MedVenture Regulatory Affairs Specialist MedVenture Technology Corporation 2400 Crittenden Drive Louisville, KY 40217

Re: K984600/S1 Metra Positioning System (PS) Procedure Kit Dated: April 7, 1999 Received: April 9, 1999 Regulatory Class: Class II 21 CFR 876.1500/Product Code: 78 GCJ

Dear Mr. Sterrett:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). You may, therefore, market the device, subject to the general controls provisions of the Act. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this

{3}------------------------------------------------

Page 2 - Mr. Mark Sterrett

response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.

This letter will allow you to begin marketing your device as described in your 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 the labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 vours.

CAPT Daniel G. Schultz, M.D.

Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

{4}------------------------------------------------

510(k) Number (if known): K984600

Devicc Namc: Metra Positioning System (PS) Procedure Kit

Indication For Use:

This procedure kit is intended to facilitate passage of suture through the soft tissues of the body during laparoscopic surgery. It is to be used only by surgeons trained in laparoscopic surgery.

(PLEASE DO NOT WRITE BELOW THIS LNE - CONTINUE ON ANOTHER PAGE IF NECESSAY)

Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use(Per 21 CFR 801.109)	OR	Over-The Counter Use
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,and Radiological Devices	(Optional Format 1-2-96)
510(k) Number	K984600

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.