The intended use of the device here in question, i.e. the Care Wise C-Trak Automatic Analyzer, remains unchanged from the intended use of prior predicate Care Wise and other portable radioisotope detectors. The Care Wise C-Trak Automatic Analyzer is designed- as are all similar devices - to detect and quantify nuclear radiation. It is indicated for external and intraoperative detection of radioactivity in body tissues or organs, such as bowel, bone, lymphatics, and red blood cells, where radiopharmaceuticals are administered.

Device Description

The Care Wise C-Trak Automatic Analyzer consists of a battery-powered analyzer designed to operate a hand held probe, display the data from the detected radiation, and display and control the system's operating parameters.

AI/ML Overview

Based on the provided text, the device in question, the "Care Wise C-Trak® Automatic Analyzer," is a portable radioisotope detector. The document describes its intended use and establishes its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a specific study proving the device meets those criteria.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed study with acceptance criteria for a new clinical performance claim. Therefore, much of the requested information cannot be found in the provided text.

Here's a breakdown of what can and cannot be answered:

1. A table of acceptance criteria and the reported device performance

Cannot be found in the provided text. The document asserts the device's function (to detect and quantify nuclear radiation) but does not define specific performance metrics or acceptance criteria for that function. It relies on the substantial equivalence to predicate devices, implying that if the predicate devices meet performance standards, this device, being equivalent, also meets them.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Cannot be found in the provided text. There is no mention of a specific test set, patient data, sample size, or study design (retrospective/prospective).

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)

Cannot be found in the provided text. No ground truth establishment related to a test set is discussed.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Cannot be found in the provided text. There is no mention of an adjudication process.

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

Cannot be found in the provided text. This device is a radioisotope detector, not an AI-assisted diagnostic tool for image interpretation by human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable to this device type and is not mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Cannot be found in the provided text. While the device "detects and quantifies nuclear radiation" automatically, the document doesn't provide performance data for this "standalone" functionality or describe a specific study for it. The focus is on substantial equivalence, implying its performance is comparable to existing devices.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Cannot be found in the provided text. Since no specific study with a test set is outlined, the type of ground truth used is not mentioned.

8. The sample size for the training set

Not applicable / Cannot be found in the provided text. This device is a physical instrument for radiation detection, not a machine learning or AI model that requires a training set in the typical sense.

9. How the ground truth for the training set was established

Not applicable / Cannot be found in the provided text. As this is not an AI/ML device requiring a training set, the establishment of ground truth for such a set is not relevant and not discussed.

Summary of available information related to "study" and "demonstration of effectiveness":

The primary "study" or justification for the device's effectiveness and safety, as described in this 510(k) summary, is its substantial equivalence to predicate devices.

Predicate Devices:
- NeoProbe 1000 and 1500 Analyzers (K971167)
- Care Wise C-Trak® Biopsy System (K922117)
- Care Wise OncoProbe II™ Analyzer (K896588)
- Other products marketed before May 28, 1976 (Medical Device Amendments)
Documentation for Substantial Equivalence:
- Page 65A of Volume 17 of the Journal of Nuclear Medicine, January 1976 (enclosed as Attachment V).
- NeoProbe promotional literature (enclosed as Attachment VI).
Safety Aspects Mentioned:
- Comprehensive shielding of high voltage sites.
- Operation only from internal batteries (eliminates electrical current leakage risks).
- Designed for safe operation in an operating room environment, provided flammable anesthetic gases are not used.

In essence, the document confirms the device's regulatory clearance based on its similarity to existing, approved devices, rather than presenting a new, dedicated performance study with defined acceptance criteria.

Summary

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

29-1998 9:51AM

K982442

AUG 25 1998

510 (k) SUMMARY

Care Wise Medical Products Corporation's (Care Wise) C-Trak® Automatic Analyzer and Accessories

Submitter's name, Address, Telephone Number, Contact Person and Date Prepared

Submitter Care Wise Medical Products Corporation 700-A East Dunne Avenue Morgan Hill, CA 95037

Contact Person Robin A. Wise, Jr. President Care Wise Medical Products Corporation (408) 779-5531 Phone: FAX: (408) 779-3185

July 28, 1998 Date Prepared:

Name of Device and Name/Address of Sponsor

C-Trak® Automatic Analyzer

Care Wise Medical Products Corporation 700-A East Dunne Avenue Morgan Hill, CA 95037 (408) 779-5531 Phone: FAX: (408) 779-3185

Common or Usual Name

Portable Radioisotope Detectors and Accessories

Classification Name

Nuclear Uptake Probe and Accessories

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

Predicate Devices

NeoProbe 1000 and 1500 Analyzers and accessories currently marketed by the NeoProbe Corporation of Dublin, Ohio (K971167)

Care Wise C-Trak® Biopsy System (K922117)

Care Wise OncoProbe II™ Analyzer (K896588)

Intended Use

The intended use of the device here in question, i.e. the Care Wise C-Trak® Automatic Analyzer, remains unchanged from the intended use of prior predicate Care Wise and other portable radioisotope detectors. The Care Wise C-Trake Automatic Analyzer is designed- as are all similar devices - to detect and quantify nuclear radiation. It is indicated for external and intraoperative detection of radioactivity in body tissues or organs, such as bowel, bone, lymphatics, and red blood cells, where radiopharmaceuticals are administered.

Device Description

The Care Wise C-Trak® Automatic Analyzer consists of a battery-powered analyzer designed to operate a hand held probe, display the data from the detected radiation, and display and control the system's operating parameters.

Safety and Effectiveness

Comprehensive shielding of high voltage sites within the instrument and operation only from internal batteries eliminate the possibility of significant electrical current leakage to patient or user under normal operating conditions. The C-Trak system's electrical safety is greatly enhanced by the fact that the system is not designed or manufactured to be connected to an AC power line or any other type of external power supply. The system has been designed and manufactured for safe operation in an operating room environment, as long as flammable anesthetic gasses are not used.

Care Wise Medical Products Corporation believes that the C-Trak® Automatic Analyzer is substantially equivalent not only to each of its other analyzer products but also to products marketed before the passage of the Medical Amendments of May 28, 1976 and to other products such as the NeoProbe 1000 and 1500 Analyzers currently marketed by the NeoProbe Corporation of Dublin, Ohio. Documentation for this opinion is found on page 65A of Volume 17 of the Journal of Nuclear Medicine, January 1976, enclosed as Attachment V of this application and in NeoProbe promotional literature enclosed in Attachment VI. We intend to market both this and previously cleared technologies.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged around a circular seal. Inside the seal is a stylized representation of a human figure, with three overlapping profiles suggesting a sense of community and support. The design is simple and uses a monochromatic color scheme.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 25 1998

Robin A. Wise, Jr. President Care Wise Medical Products Corporation PO Box 1655 Morgan Hill, CA 95038-1655

Re:

K982442 C-Trak Automatic Analyzer Dated: July 13, 1998 Received: July 14, 1998 Regulatory class: I 21 CFR 892.1320/Procode: 90 IZD

Dear Mr. Wise:

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 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 (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 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 510Ks premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predication 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 disgnostic 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/dsmaldsmaman.html".

Sincerely yours,

Kilian Yin

Lillian Yin. Ph.D Director, Division of Reproductive Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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7-29-1998 9:51AM

Page of

511)(k) 1 'umber (if known): __ K 78244

Device Jame: C-Trak Automatic Analyzer

Indicati. ns For Use:

The intended use of the device here in question, i.e. the Care Wise Automatic Analyzer, remains unchanged from the intended use C-Trak of prior predicate Care Wise and other portable radioisotope detectors. The Care Wise C-Trak Automatic Analyzer is designed-as are all similar devices- to detect and guantify the nuclear radiation. It is indicated for external and intraoperative detection of radioactivity in body tissues or organs, such as bowel, bone, lymphatics, and red blood cells, where radiopharmaceuticals are administered.

(PI EASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David H. Ingram

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K982442

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 892.1320 Nuclear uptake probe.

(a)
Identification. A nuclear uptake probe is a device intended to measure the amount of radionuclide taken up by a particular organ or body region. This generic type of device may include a single or multiple detector probe, signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.