The Neoprobe® Model 1500 Portable Radioisotope Detector is an electronic device intended to detect and quantify gamma 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 Neoprobe® Model 1500 Portable Radioisotope Detector ("Model 1500") consists of (1) a microcomputer-based control unit: (2) a 12 mm collimated detector probe tip, a 12 mm non-collimated detector probe tip, and a 19 mm noncollimated probe tip, all of which are reusable, steam sterilizable and contain a cadmium zinc telluride crystal gamma ray detector; (3) a disposable sterile probe handle with an attached polypropylene cable; (4) a check source disk containing a known quantity of 1201; and (5) a chrome-plated Teflon-lined lead noise adjustment fixture used for periodic verification that the system continues to meet factory calibration readings.

AI/ML Overview

Based on the information provided in the 510(k) summary (K971167) for the Neoprobe Model 1500 Portable Radioisotope Detector, here's a breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The device is seeking substantial equivalence to predicate devices, particularly the Neoprobe Model 1000 GEN 1C. Therefore, the "acceptance criteria" are implicitly the functional performance characteristics of the predicate device, especially its 11mm EtO sterilizable detector probe, and the "reported device performance" are the measurements obtained for the new Model 1500's 12mm probes.

Acceptance Criteria (Implicitly, Performance of Predicate Device's 11mm probe)	Reported Device Performance (Model 1500's 12mm probes)
Counting Efficiency: Function of probe to source distance for 135I, 111In, and 99mTc (specific values not provided in summary)	Counting Efficiency: Demonstrated to be "functionally equivalent" except for predicted change due to crystal dimension, with "counts per second per unit area of detector surface" being the same.
Spatial Resolution: For 135I, 111In, and 99mTc (specific values not provided in summary)	Spatial Resolution: Demonstrated to be "functionally equivalent" to the 11mm probe.
Interchangeability: (Not applicable to predicate as it refers to new probes)	Interchangeability: Collimated and non-collimated versions of reusable, steam sterilizable detector probes can be used interchangeably with the Model 1500 control unit with the same disposable handle, without adjustments.
Material/Sterilization Equivalence: (Specifically for the 11mm EtO sterilizable probe)	Material/Sterilization Equivalence: Demonstrated for new 12mm reusable, steam sterilizable probes.

2. Sample Size Used for the Test Set and the Data Provenance

The summary describes laboratory studies to demonstrate functional equivalence.

Sample Size: Not explicitly stated as a number of probes or trials. It refers to general testing of "the cleared 11 mm and the new 12 mm collimated and non-collimated probe tips." This implies testing of at least one of each type of probe.
Data Provenance: The studies were laboratory studies conducted by Neoprobe Corporation. No specific country of origin for the data is mentioned, but it can be inferred to be from the company's location (Dublin, OH, USA). The studies are inherently prospective as they were specifically designed and executed for this 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This type of information is not applicable to the described study. The study focused on technical performance characteristics (counting efficiency, spatial resolution) of the device itself, rather than diagnostic accuracy requiring expert interpretation of clinical data. The "ground truth" for these measurements would be physical standards and known radioactive sources.

4. Adjudication Method for the Test Set

This is not applicable. There was no human interpretation or diagnostic decision-making involved in the laboratory performance tests that would require adjudication. The measurements were objective physical science tests.

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

No, an MRMC comparative effectiveness study was not done. This device is a radioisotope detector, not an AI-powered diagnostic tool. The submission focuses on the hardware's functional equivalence.

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

Yes, in essence. The laboratory studies directly assessed the performance of the device's detector probes (counting efficiency, spatial resolution) independently of a human operator, making it a "standalone" performance evaluation of the hardware components. There is no "algorithm" in the sense of artificial intelligence.

7. The Type of Ground Truth Used

The ground truth used for these laboratory studies would be based on:

Known Radioactive Sources: Standardized sources of 135I, 111In, and 99mTc with known activities and decay characteristics.
Physical Measurement Standards: Accurate measurement tools for distance and physical arrangements to determine spatial resolution.
Engineering Specifications: Comparison against expected physical and engineering principles for gamma ray detection.

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" in the context of this device's submission. The device is a hardware instrument, not a machine learning model that requires training data.

9. How the Ground Truth for the Training Set Was Established

This is not applicable as there is no training set for this hardware device.

Summary

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K971167

510(k) SUMMARY

JUN 26 1997

Neoprobe Corporation's Model 1500 Portable Radioisotope Detector and Accessories

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

Submitter Neoprobe Corporation 425 Metro Place North Suite 400 Dublin. OH 43017-1367

Contact Person Susan D. Tiedy-Stevenson Director of Regulatory Affairs Neoprobe Corporation Phone: (301) 620-9416 Facsimile: (301) 620-1438

Date Prepared: March 28, 1997

Name of Device and Name/Address of Sponsor

Neoprobe Model 1500 Portable Radioisotope Detector and Accessories

Neoprobe Corporation 425 Metro Place North Suite 400 Dublin, OH 43017-1367 Phone: (614) 793-7500 Facsimile: (614) 793-7520

Common or Usual Name

Radioisotope detector and accessories

Classification Name

Nuclear uptake probe and accessories

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Predicate Devices

Neoprobe Model 1000 GEN 1C Portable Radioisotope Detector and Accessories (K962319).

CareWise C-Trak Biopsy System (K922117)

Intended Use

Device Description

Safety and Effectiveness

The Model 1500 is substantially equivalent to the Model 1000 GEN 1C, which received premarket clearance in 1996 (K92319). This submission covers modifications to the device since the Model 1000 GEN 1C received premarket clearance. These modifications include: (1) a modified control unit, (2) a disposable detector probe handle with attached cable, (3) a 12 mm noncollimated reusable, steam sterilizable detector probe tip, (4) a 12 mm collimated reusable, steam sterilizable reusable detector probe tip, and (5) a 19 mm noncollimated reusable, steam sterilizable detector probe tip. These modifications are intended to facilitate rapid and efficient probe interchangeability and to offer more options to the user.

Neoprobe has conducted laboratory studies to demonstrate the functional equivalence of the Model 1500 12 mm reusable, steam sterilizable noncollimated and collimated detector probe tips to the cleared Model 1000 GEN 1C 11 mm, EtO sterilizable detector probe. The tests performed on the cleared 11 mm and the new 12 mm collimated and non-collimated probe tips included measurement of the counting efficiency as a function of probe to source distance for 1351, 1111n and

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99mTc, and measurement of the spacial resolution of the probe tip with and without collimation for the three nuclides.

The results obtained with the cleared 11 mm probe and the new 12 mm probe tips demonstrate that the two types of detector probes are functionally equivalent except for the change in count rate that is predicted from the change in dimensions of the crystal. In terms of counts per second per unit, area of detector surface were the same for both the 11 mm and the 12 mm detector probe tips. The collimated and non-collimated versions of the reusable, steam sterilizable detector probes can be used interchangeably with the Neoprobe® 1500 control unit with the same disposable handle, without adjustments.

Neoprobe has submitted in previous 510(k) notifications (including K942580 and K864263) literature in support of the indications for use for which the company is seeking clearance in this submission. Specifically, literature has been supplied to FDA on the use of various radiopharmaceutical compounds and detector probes for intraoperative identification of areas with increased radionuclide concentration to support the use of Neoprobe's device during ischemic bowel, bone (osteoid osteoma), thyroid and colon applications. In addition, this 510(k) notice includes literature that supports the use of Neoprobe's Model 1500 for detection of radioactivity in lymphatics.

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Image /page/3/Picture/0 description: The image shows a logo for the Department of Health & Human Services. The logo features a stylized image of an eagle with three curved lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN" are arranged in a circular pattern around the eagle image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Susan Tiedy-Stevenson, M.S. Director, Regulatory Affairs Neoprobe Corporation 425 Metro Place North, Suite 400 Dublin, OH 43017-1367

Re: K971167

Neoprobe® Model 1500 Portable Radioisotope Detector and Accessories Dated: March 28, 1997 Received: March 31, 1997 Regulatory Class: I 21 CFR 892.1320/Procode: 90 IZD

JUN 26 1997

Dear Ms. Tiedy-Stevenson:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have decemined 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (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 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 does not affect any obligation you might have under secsions 51 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 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 diagnostic devices), please contact the Office of Compliance at (301) 594-4591 for Radiology devices, or 594-613 for Ear, Nose and Throat devices. 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.

iyh

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

Enclosure

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Neoprobe Model 1500 Portable Radioisotope Detector

Indications For Use:

The Neoprobe Model 1500 Portable Radioisotope Detector is an electronic device intended to detect and quantify gamma 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. For proper use and limitations of the Neoprobe Model 1500 refer to the product labeling.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Segym

(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radio!ogical Devices 510(k) Number -

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.