(157 days)
Not Found
No
The summary describes a mechanical surgical instrument kit and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
No.
The device components (suture passer, grasper, knot pusher, suture material) are tools used to facilitate a surgical procedure (passing suture), rather than directly treating or mitigating a disease or condition itself.
No
Explanation: The device is intended to facilitate the passage of suture during laparoscopic surgery, which is a therapeutic rather than diagnostic function. It is a surgical tool, not a device used for identifying diseases or conditions.
No
The device description explicitly lists physical components (needle point suture passer, grasper, knot pusher/positioning device, suture material, suture guides), indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "facilitate passage of suture through the soft tissues of the body during laparoscopic surgery." This describes a surgical tool used in vivo (within the living body) for a surgical procedure.
- Device Description: The components listed (suture passer, grasper, knot pusher, suture material, suture guides) are all instruments used directly on the patient's tissues during surgery.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to examine specimens taken from the human body (like blood, urine, tissue samples) to provide information about a person's health status. This device does not perform such analysis on specimens.
Therefore, this device falls under the category of surgical instruments used for direct intervention on the patient, not for in vitro diagnostic testing.
N/A
Intended Use / Indications 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.
Product codes (comma separated list FDA assigned to the subject device)
78 GCJ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissues of the body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeons trained in laparoscopic surgery
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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
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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
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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 |