(51 days)
The Mentor Injection Port Detector is used to locate Mentor Tissue Expander remote and integral injection ports. The device is nonsterile and for postoperative use only.
The Mentor H/S Injection Port Detector is a hand-held battery operated, rechargeable unit which detects the stainless steel needle guard located inside remote and integral tissue expander injection ports. When not in use, the device rests in a charging cradle to maintain full charge. The device contains electro magnetic coils and circuitry which detects changing magnetic fields. The presence of an iniection port near the coils causes a change in the magnetic field, which in turn induces a current in the coils. An LED display indicates when the center of the injection port has been located.
The provided document is a 510(k) summary for the Mentor Injection Port Detector (IPD), a device designed to locate injection ports of Mentor Tissue Expanders. It largely focuses on establishing substantial equivalence to a predicate device rather than presenting a detailed study evaluating its performance against specific acceptance criteria. While the substantial equivalence claim implies a certain level of performance, the document does not contain the detailed study information typically requested.
Therefore, many of the requested fields cannot be directly answered from the provided text. However, based on the available information, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria or report specific performance metrics for the Mentor Injection Port Detector in a table format. The core of the submission is the claim of substantial equivalence to the Mentor Accu-Tec™ Injection Port Detector (K905484), implying that its performance is comparable to an already legally marketed device.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not provided in the document. The submission appears to rely on the established performance of the predicate device and the design similarities for its substantial equivalence claim, rather than new performance testing data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This information is not provided in the document.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not provided in the document.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable to this device. The Mentor Injection Port Detector is a standalone device, not an AI-assisted tool for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
The device itself is a standalone, hand-held, battery-operated unit that detects injection ports. While the document doesn't detail a specific "standalone performance study" in the modern sense (e.g., deep learning algorithm evaluation), it describes the device's mechanism: "The Mentor H/S Injection Port Detector is a hand-held battery operated, rechargeable unit which detects the stainless steel needle guard located inside remote and integral tissue expander injection ports... An LED display indicates when the center of the injection port has been located." This implies its intended use is as a standalone diagnostic aid.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided in the document. For a device like this, the "ground truth" for its function would likely be the actual physical location of the stainless steel needle guard within the injection port, confirmed by visual inspection or other established methods, but such details are not explicitly stated.
8. The sample size for the training set
This information is not provided in the document. Given the device's nature (electromagnetic detection, not an AI/machine learning algorithm), the concept of a "training set" as typically understood for AI is not directly applicable. Its design is based on fundamental principles of electromagnetism.
9. How the ground truth for the training set was established
This information is not provided in the document. As mentioned for point 8, the concept of a training set for this type of device is not directly applicable. The device's operation is based on its electro-magnetic design.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three heads facing right, representing service to the people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle symbol.
SEP 27 1996
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Ronald F. Lagerquist Regulatory Affairs Analyst Mentor Corporation 5425 Hollister Avenue Santa Barbara, California 93111
Re : K963066 Mentor Injection Port Detector (IPD) Trade Name: Requlatory Class: Unclassified Product Code: LCJ Dated: August 2, 1996 Received: August 7, 1996
Dear Mr. Lagerquist:
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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in Please note: this response to your the Federal Reqister. 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 - Mr. Ronald F. Lagerquist
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA described in your 510 wi providence of your device to a legally marketed predicate device results in a classification for your marketed predicate device rebared in the to proceed to the market.
If you desire specific advice for your device on our labeling II you desire bpccirie additionally 809.10 for in regulation (21 eldevices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on Compriance at (302) 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 enc regaracen ication" (21 CFR 807.97). Other general information on your responsibilities under the Act may be Information on your of Small Manufacturers Assistance obtained from eno Dree (800) 638-2041 or at (301) 443-6597.
Sincerely yours,
Mark N. Mulhausen
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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长963066 510(k) Number (if known):
Device Name: MENTOR Injection Port Detector
Indications For Use:
((
The Mentor Injection Port Detector is used to locate Mentor Tissue Expander remote and integral injection ports. The device is nonsterile and for postoperative use only.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark N Milkerson
for
CMW
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K963066
Prescription Use (Per 21 CFR 801.109)
OR
Over-The Counter Use_
(Optional Format 1-2-96)
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Image /page/3/Picture/0 description: The image shows the logo for Mentor Corporation. The logo consists of a symbol that looks like four arrows pointing outwards from a central point. To the right of the symbol is the word "MENTOR" in large, bold letters, and below that is the word "CORPORATION" in smaller letters.
Executive Offices 5425 Hollister Avenue
Santa Barbara, CA 93111
(805) 681-6000
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: Ronald F. Lagerquist Regulatory Affairs Analyst Mentor Corporation 5425 Hollister Ave. Santa Barbara, CA 93111
(805) 681-6000 Telephone: FAX: (805) 681-6004
August 2, 1996 Date Prepared:
Device Name
Proprietary Name: Mentor Injection Port Detector
Common Name: Injection Port Detector
Substantial Equivalence Claim
The Mentor H/S Injection Port Detector is similar in indications, design and features to the Mentor Accu-Tec™ Injection Port Detector (K905484).
Indications For Use
The Mentor H/S Injection Port Detector is used to detect Mentor Tissue Expander remote and integral injection ports. The device is nonsterile and for postoperative use only.
Device Description
The Mentor H/S Injection Port Detector is a hand-held battery operated, rechargeable unit which detects the stainless steel needle guard located inside remote and integral tissue expander injection ports. When not in use, the device rests in a charging cradle to maintain full charge.
The device contains electro magnetic coils and circuitry which detects changing magnetic fields. The presence of an iniection port near the coils causes a change in the magnetic field, which in turn induces a current in the coils. An LED display indicates when the center of the injection port has been located.
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N/A