(88 days)
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No
The description focuses on the hardware and basic functionality of detecting and quantifying gamma radiation, with no mention of AI or ML algorithms for data analysis or interpretation.
No
This device is described as a detector of gamma radiation and radioactivity, not a device that applies therapy.
Yes
The device is intended for the "external and intraoperative detection of radioactivity in body tissues or organs," which implies it is used to gather information about the state of the body (presence and quantification of gamma radiation) to aid in diagnosis or treatment planning.
No
The device description explicitly lists multiple hardware components including a control unit, detector probe, cable, check source, and noise adjustment fixture.
Based on the provided information, the Neoprobe Model 1000 GEN 1C Portable Radioisotope Detector is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's 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 definition of in vitro).
- Device Description: The description details a device for detecting gamma radiation from administered isotopes in vivo.
- No mention of in vitro analysis: There is no mention of analyzing blood, urine, tissue samples, or any other biological material outside the body.
Therefore, this device falls under the category of an in vivo diagnostic or therapeutic device (depending on the specific medical procedure it's used in), not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Neoprobe Model 1000 GEN 1C Portable Radioisotope Detector is an electronic device intended to detect and quantify gamma radiation. The GEN 1C in indicated for external and intraoperative detection of radioactivity in body tissues or organs in medical procedures where gamma emitting isotopes are administered.
Product codes
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Device Description
The Neoprobe Model 1000 GEN 1C Portable Radioisotope Detector ("Model 1000") consists of a microcomputer-based control unit, a cadmium zinc telluride gamma ray detector probe, a cable used to connect the probe to the control unit, a check source containing a known quantity of 129 I, and a chrome-plated Teflon-lined lead noise adjustment fixture used for periodic verification that the system continues to meet factory calibration readings. The detector probe is available in two sizes: (1) a detector probe with a 19 mm external diameter and a detector diameter of 15 mm; and (2) a detector probe with an 11 mm external diameter and a detector diameter of 7 mm. Optional accessories include a detector probe collimator and a detector probe shield.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
body tissues or organs
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Neoprobe has conducted laboratory studies to demonstrate the functional equivalence of the 11 mm GEN 1C probes to the predicate Model 1000 GEN 1B probe. These tests included: (1) a comparison of the counting efficiencies of six randomly selected 11 mm GEN 1C probes using a calibrated source of 129; (2) measurement of the counting efficiency of a representative probe as a function of probe-to-source distance for 1251, 1111In, and 900Tc; and (3) measurement of the spatial resolution of the probe with and without collimation for the three nuclides. In summary, the counting efficiency of the 11 mm GEN 1C probes was found to be functionally equivalent to the counting efficiency of the predicate 19 mm Model 1000 GEN 1B probe.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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510(k) SUMMARY
Neoprobe Corporation's Model 1000 GEN 1C 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 (614) 793-7500 Phone: (614) 793-7520 Facsimile:
SEP 1 3 1996
Contact Person Susan D. Tiedy-Stevenson Director of Regulatory Affairs Neoprobe Corporation (301) 620-9416 Phone: (301) 620-1438 Facsimile:
June 14, 1996 Date Prepared:
Name of Device and Name/Address of Sponsor
Neoprobe Model 1000 GEN 1C Portable Radioisotope Detector and Accessories
Neoprobe Corporation 425 Metro Place North Suite 400 Dublin, OH 43017-1367 (614) 793-7500 Phone: (614) 793-7520 Facsimile:
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Common or Usual Name
Radioisotope detector and accessories
Classification Name
Nuclear uptake probe and accessories
Predicate Device
Neoprobe Model 1000 GEN 1B Portable Radioisotope Detector and Accessories (K942580)
Intended Use
The Neoprobe Model 1000 GEN 1C Portable Radioisotope Detector is an electronic device intended to detect and quantify gamma radiation. The GEN 1C in indicated for external and intraoperative detection of radioactivity in body tissues or organs in medical procedures where gamma emitting isotopes are administered.
Technological Characteristics and Substantial Equivalence
Device Description
The Neoprobe Model 1000 GEN 1C Portable Radioisotope Detector ("Model 1000") consists of a microcomputer-based control unit, a cadmium zinc telluride gamma ray detector probe, a cable used to connect the probe to the control unit, a check source containing a known quantity of 129 I, and a chrome-plated Teflon-lined lead noise adjustment fixture used for periodic verification that the system continues to meet factory calibration readings. The detector probe is available in two sizes: (1) a detector probe with a 19 mm external diameter and a detector diameter of 15 mm; and (2) a detector probe with an 11 mm external diameter and a detector diameter of 7 mm. Optional accessories include a detector probe collimator and a detector probe shield.
Safety and Effectiveness
The GEN 1C is substantially equivalent to its predecessor, the Model 1000 GEN 1B, which received premarket clearance in 1995 (K942580). The GEN 1C is identical to the predicate device in general intended use, design, and principle of operation. The only differences between the GEN 1C and the predicate device are the use of a singlepiece aluminum probe cap rather than a probe cap comprised of multiple parts, addition of a smaller (11 mm) detector probe, and use of a two millimeter radioactive
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encapsulated area (check source) with the existing 19 mm probe and with the 11 mm detector probe. These minor differences raise no new issues of safety or effectiveness because the modified device continues to perform identical functions in the same manner as the predicate device.
Performance Data
Neoprobe has conducted laboratory studies to demonstrate the functional equivalence of the 11 mm GEN 1C probes to the predicate Model 1000 GEN 1B probe. These tests included: (1) a comparison of the counting efficiencies of six randomly selected 11 mm GEN 1C probes using a calibrated source of 129; (2) measurement of the counting efficiency of a representative probe as a function of probe-to-source distance for 1251, 1111In, and 900Tc; and (3) measurement of the spatial resolution of the probe with and without collimation for the three nuclides. In summary, the counting efficiency of the 11 mm GEN 1C probes was found to be functionally equivalent to the counting efficiency of the predicate 19 mm Model 1000 GEN 1B probe.