← Product Code [IZD](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZD) · K962319 # NEOPROBE 1000 GEN 1C PORTABLE RADIOISOTOPE DETECTOR & ACCESSORIES (K962319) _Neoprobe Corp. · IZD · Sep 13, 1996 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZD/K962319 ## Device Facts - **Applicant:** Neoprobe Corp. - **Product Code:** [IZD](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZD.md) - **Decision Date:** Sep 13, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.1320 - **Device Class:** Class 1 - **Review Panel:** Radiology ## 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 is indicated for external and intraoperative detection of radioactivity in body tissues or organs in medical procedures where gamma emitting isotopes are administered. ## Device Story Device is a microcomputer-based control unit with a cadmium zinc telluride (CZT) gamma ray detector probe. Used in clinical settings for external and intraoperative detection/quantification of gamma radiation in tissues/organs following administration of gamma-emitting isotopes. System includes control unit, probe, cable, check source (129I), and noise adjustment fixture. Optional accessories include collimators and shields. Physician operates device to locate radioactive tracers; output provides radioactivity counts to assist in surgical or diagnostic localization. Benefits include precise identification of radioactive tissues during procedures. ## Clinical Evidence Bench testing only. Laboratory studies compared 11 mm GEN 1C probes to the predicate 19 mm GEN 1B probe. Testing included counting efficiency comparisons using 129I, counting efficiency vs. distance for 125I, 111In, and 99mTc, and spatial resolution measurements with/without collimation. Results demonstrated functional equivalence between the 11 mm GEN 1C probes and the predicate 19 mm probe. ## Technological Characteristics Microcomputer-based control unit; cadmium zinc telluride (CZT) gamma ray detector; probe diameters 11 mm and 19 mm; aluminum probe cap; check source (129I); noise adjustment fixture (chrome-plated, Teflon-lined lead). ## Regulatory 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. ## Predicate Devices - Neoprobe Model 1000 GEN 1B Portable Radioisotope Detector and Accessories ([K942580](/device/K942580.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} SEP 13 1996 K 9623/9 510(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 Phone: (614) 793-7500 Facsimile: (614) 793-7520 Contact Person Susan D. Tiedy-Stevenson Director of Regulatory Affairs Neoprobe Corporation Phone: (301) 620-9416 Facsimile: (301) 620-1438 Date Prepared: June 14, 1996 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 Phone: (614) 793-7500 Facsimile: (614) 793-7520 {1} 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 is 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 $^{129}\mathrm{I}$, 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 single-piece 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 2 {2} 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 $^{129}\mathrm{I}$; (2) measurement of the counting efficiency of a representative probe as a function of probe-to-source distance for $^{125}\mathrm{I}$, $^{111}\mathrm{In}$, and $^{99\mathrm{m}}\mathrm{Tc}$; 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. --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZD/K962319](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZD/K962319) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com