(72 days)
No
The device description and intended use are purely mechanical and do not mention any computational or data-driven components.
No
A therapeutic device is one that treats or cures a disease or condition. This device is an access port for surgical instruments and does not treat or cure a disease itself.
No
The device, Mentor Pathway Introducer, is described as an operating port, dilator, and plug used during lipoplasty surgery for instrument insertion and access, not for diagnosing conditions or diseases.
No
The device description clearly outlines physical components (Introducer, Dilator, Plug) made of materials intended for surgical use, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
- Device Function: The Mentor Pathway Introducer/Dilator system is a surgical tool used during a surgical procedure (lipoplasty surgery) to create and maintain an access port into the body. It facilitates the insertion of other surgical instruments.
- Intended Use: The intended use clearly states it's for use as an operating port at the skin insertion site when instruments are utilized beneath the dermal layer. This is an in-vivo (within the living body) application, not an in-vitro one.
- Device Description: The description details a physical device used for surgical access, not for analyzing biological specimens.
Therefore, the function and intended use of this device fall outside the scope of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Mentor Pathway Introducer is indicated for use as an operating port at the skin insertion site when instruments are utilized beneath the dermal layer for lipoplasty surgery applications. The Dilator is indicated for dilating the dermal layer and aiding in the insertion of the Pathway Introducer. The Plug is indicated for sealing the lumen of the Pathway Introducer when not in use.
Product codes
OPB, MUU
Device Description
The Mentor Pathway Introducer/Dilator system consists of three (3) primary components: Introducer, Dilator and Plug.
The Dilator consists of a dilating stem and a handle. It is used to facilitate the insertion of the Introducer.
The Pathway Introducer consists of a threaded distal end which is threaded into the skin at the insertion site, and a conical section which remains outside the skin. There is a longitudinal hole in the Introducer through which a cannula and sheath (or other similar surgical instrumentation) are inserted, and there is a seal inside the hole which wipes excess liquid from the cannula and sheath during withdrawal. The Introducer acts as an access port during the insertion of cannulae and other operating instruments to a desired surgical site beneath the dermal layer.
The Plug is used to seal the lumen of the Pathway Introducer when not in use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skin insertion site
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.5040 Suction lipoplasty system.
(a)
Identification. A suction lipoplasty system is a device intended for aesthetic body contouring. The device consists of a powered suction pump (containing a microbial filter on the exhaust and a microbial in-line filter in the connecting tubing between the collection bottle and the safety trap), collection bottle, cannula, and connecting tube. The microbial filters, tubing, collection bottle, and cannula must be capable of being changed between patients. The powered suction pump has a motor with a minimum of1/3 horsepower, a variable vacuum range from 0 to 29.9 inches of mercury, vacuum control valves to regulate the vacuum with accompanying vacuum gauges, a single or double rotary vane (with or without oil), a single or double diaphragm, a single or double piston, and a safety trap.(b)
Classification. Class II (special controls). Consensus standards and labeling restrictions.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Mentor Corp. Donna Crawford Manager, Corporate Regulatory Affairs 5425 Hollister Ave. Santa Barbara, California 93111
June 8, 2021
Re: K981527
Trade/Device Name: Mentor Pathway Introducer/dilator Regulation Number: 21 CFR 878.5040 Regulation Name: Suction lipoplasty system Regulatory Class: Class II Product Code: OPB
Dear Donna Crawford:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated July 9, 1998. Specifically, FDA is updating this SE Letter because FDA has created a new product code to better categorize your device technology.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Cindy Chowdhury, OHT4: Office of Surgical and Infection Control Devices, 240-402-6647, Cindy.Chowdhury@fda.hhs.gov.
Sincerely,
Cindy Chowdhury -S
Cindy Chowdhury, Ph.D., M.B.A. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is positioned to the right of a circular text element that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
0 1098 JUL
Ms. Donna A. Crawford Manager, Corporate Regulatory Affairs Mentor Corporation 5425 Hollister Avenue Santa Barbara, California 93111
Re: K981527
Trade Name: Mentor Pathway Introducer/Dilator Regulatory Class: II Product Code: MUU Dated: April 24, 1998 Received: April 28, 1998
Dear Ms. Crawford:
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 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. The general controls provisions of the Act include requirements for annual registration, listing 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 (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 requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this 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.
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Page 2 - Ms. Donna A. Crawford
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 our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):_ 长 98 / 527
Device Name: MENTOR Pathway™ Introducer/Dilator
Indications For Use:
The Mentor Pathway Introducer is indicated for use as an operating port at the skin insertion site when instruments are utilized beneath the dermal layer for lipoplasty surgery applications. The Dilator is indicated for dilating the dermal layer and aiding in the insertion of the Pathway Introducer. The Plug is indicated for sealing the lumen of the Pathway Introducer when not in use.
(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 Devices | |
| 510(k) Number | K981527 |
Prescription Use V (Per 21 CFR 801.109)
OR
Over-The Counter Use
(Optional Format 1-2-96)
4
K 981527
510(k) SUMMARY
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92.
The assigned 510(k) number is:
Submitted by: Donna A. Crawford Manager, Corporate Regulatory Affairs Mentor Corporation 5425 Hollister Ave. Santa Barbara, CA 93111
Telephone: (805) 681-6000 extension 304 FAX: (805) 681-6004
Date Prepared: April 24, 1998
Device Name
Proprietary Name: Mentor Pathway™ Introducer/Dilator
Common Name: Introducer/Dilator
Substantial Equivalence Claim
The Mentor Pathway Introducer/Dilator is similar to devices used to dilate the skin and provide an access port for surgical procedures. Examples of equivalent devices include the Ethicon Non-shielded Surgical Trocar (K963760), the Ximed surgical trocars and cannulae (K933458) and the Applied Medical Technology Endoscopic Access Device (K960232). The Mentor Pathway Introducer/Dilator is also similar in design and intended use to the Lysonix Lipoplasty Access Port (K980763).
Indications For Use
The Mentor Pathway Introducer is indicated for use as an operating port at the skin insertion site when instruments are utilized beneath the dermal layer for lipoplasty surgery applications. The Dilator is indicated for dilating the dermal layer and aiding in the insertion of the Pathway Introducer. The Plug is indicated for sealing the lumen of the Pathway Introducer when not in use.
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510(k) SUMMARY Page 2 of 2
Device Description
The Mentor Pathway Introducer/Dilator system consists of three (3) primary components: Introducer, Dilator and Plug.
The Dilator consists of a dilating stem and a handle. It is used to facilitate the insertion of the Introducer.
The Pathway Introducer consists of a threaded distal end which is threaded into the skin at the insertion site, and a conical section which remains outside the skin. There is a longitudinal hole in the Introducer through which a cannula and sheath (or other similar surgical instrumentation) are inserted, and there is a seal inside the hole which wipes excess liquid from the cannula and sheath during withdrawal. The Introducer acts as an access port during the insertion of cannulae and other operating instruments to a desired surgical site beneath the dermal layer.
The Plug is used to seal the lumen of the Pathway Introducer when not in use.