METRA PS PROCEDURE KIT

K984600 · Inlet Medical, Inc. · GCJ · Jun 3, 1999 · Gastroenterology, Urology

Device Facts

• Record ID: K984600
• Device Name: METRA PS PROCEDURE KIT
• Applicant: Inlet Medical, Inc.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Jun 3, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Metra PS Procedure Kit is a manual surgical instrument set for laparoscopic procedures. Components include needle point suture passer, grasper, knot pusher/positioning device, suture material, and two suture guides. Used by surgeons in clinical settings to facilitate suture passage through soft tissues. The kit consolidates existing surgical instruments into a single package for procedural convenience. No electronic, software, or automated components.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Manual surgical instrument kit. Components include needle point suture passer, grasper, knot pusher/positioning device, and suture guides. Non-powered, mechanical device. No software or electronic components.

Indications for Use

Indicated for patients undergoing laparoscopic surgery requiring suture passage through soft tissues. Intended for use by surgeons trained in laparoscopic procedures.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Needle Point Suture Passer Instrument Set (K980123)

Submission Summary (Full Text)

{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 [phone] 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone], 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<br>(Per 21 CFR 801.109) | OR | Over-The Counter Use |
| (Division Sign-Off) | | |
| Division of Reproductive, Abdominal, ENT,<br>and Radiological Devices | (Optional Format 1-2-96) | |
| 510(k) Number | K984600 | |