(87 days)
No
The description focuses on the hardware components and basic radiation detection functionality. There is no mention of AI, ML, or any algorithms that would suggest learning or adaptive capabilities.
No
The device is strictly for detection and quantification of gamma radiation and does not describe any therapeutic function.
Yes
The device is intended to "detect and quantify gamma radiation" in "body tissues or organs" where radiopharmaceuticals are administered, and it is indicated for "external and intraoperative detection of radioactivity," which points to its use in identifying and localizing specific physiological processes or abnormalities indicative of disease.
No
The device description explicitly lists multiple hardware components, including a control unit, detector probe tips, a disposable handle, a check source disk, and a noise adjustment fixture. This indicates it is a hardware device with associated software, not a software-only medical device.
Based on the provided information, the Neoprobe® Model 1500 Portable Radioisotope Detector is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states that the device is for "external and intraoperative detection of radioactivity in body tissues or organs". This involves detecting radiation within the body, not analyzing samples outside the body (which is the hallmark of an IVD).
- Device Description: The description details a system for detecting gamma radiation directly from tissues and organs using probes. There is no mention of collecting or analyzing biological samples like blood, urine, or tissue biopsies in a laboratory setting.
- Anatomical Site: The device is used to detect radiation in "body tissues or organs". IVDs typically analyze samples derived from these sites, but not the sites themselves directly.
In summary, the Neoprobe® Model 1500 is a device used for in vivo (within the living body) detection of radioactivity, not in vitro (in glass, or outside the living body) analysis of biological samples.
N/A
Intended Use / 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.
Product codes
90 IZD
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
body tissues or organs, such as bowel, bone, lymphatics, and red blood cells
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
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 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.
Key Metrics
Not Found
Predicate Device(s)
Neoprobe Model 1000 GEN 1C Portable Radioisotope Detector and Accessories (K962319)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
1
Predicate Devices
Neoprobe Model 1000 GEN 1C Portable Radioisotope Detector and Accessories (K962319).
CareWise C-Trak Biopsy System (K922117)
Intended 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.
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.
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
2
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.
3
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
4
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)
OR
Over-The-Counter Use
(Optional Format 1-2-96)