(242 days)
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No
The summary describes a physical applicator device and its components, with no mention of software, algorithms, or any terms related to AI or ML.
Yes
The device is intended to be used for treating superficial tumors or the tumor bed using Intraoperative High-Dose-Rate Brachytherapy (IOHDR), which is a form of radiation therapy aimed at treating disease.
No
Explanation: The device description states it is used for treating superficial tumors or tumor beds through brachytherapy, which is a form of radiation therapy, not a diagnostic procedure. It is a treatment accessory, not a diagnostic tool.
No
The device description explicitly details physical components made of liquid silicone rubber, a clamping device, source-guide tubes, and a preamended arm/clamp, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the H.A.M. Applicator is used externally or internally on the patient to deliver radiation therapy for treating tumors. This is a therapeutic device used directly on the patient's body.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
The H.A.M. Applicator is a medical device used for delivering radiation therapy, which is a treatment, not a diagnostic test performed on a specimen outside the body.
N/A
Intended Use / Indications for Use
The H.A.M. Applicator is intended to be used as an accessory to highdose-rate (HDR) remote controlled radionuclide applicator systems cleared for market by the FDA. The H.A.M. Applicator may be used externally, on the surface of the patient, to treat superficial tumors or placed internally to treat the tumor or tumor bed in a procedure known as Intraoperative High-Dose-Rate Brachytherapy (IOHDR) [a subset of Intraoperative Radiation Therapy (IORT)], during the time the treatment site is exposed surgically.
Product codes
JAQ
Device Description
The H.A.M. (Harrison-Anderson-Mick) Applicator system consists of the H.A.M. Applicator, the H.A.M. Sandwich (a clamping device) source-guide tubes, when required by certain HDR systems, and a Martin Arm/Clamp ( a preamended device manufactured by Martin Medizin-Technik) which attaches the H.A.M. Sandwich to the operating table. The H.A.M. Applicator is manufactured from liguid silicone rubber and contains between three and twenty-four embedded hollow tubes. The tubes are spaced 1 cm on center laterally and are positioned 5mm from the treatment surface.
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
surface of the patient; tumor or tumor bed
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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 892.5700 Remote controlled radionuclide applicator system.
(a)
Identification. A remote controlled radionuclide applicator system is an electromechanical or pneumatic device intended to enable an operator to apply, by remote control, a radionuclide source into the body or to the surface of the body for radiation therapy. This generic type of device may include patient and equipment supports, component parts, treatment planning computer programs, and accessories.(b)
Classification. Class II.
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Attachment 2
DEC 23 1996 Premarket Notification |510(k)| Summary
Trade Name: H.A.M. Applicator
Common Name: Applicator for remote controlled afterloading brachytherapy
Classification Name and Number: Remote controlled radionuclide applicator system (accessory), JAQ (per 21 CFR 892.5700)
Class II, Radiology Panel (90)
Description: The H.A.M. (Harrison-Anderson-Mick) Applicator system consists of the H.A.M. Applicator, the H.A.M. Sandwich (a clamping device) source-guide tubes, when required by certain HDR systems, and a Martin Arm/Clamp ( a preamended device manufactured by Martin Medizin-Technik) which attaches the H.A.M. Sandwich to the operating table. The H.A.M. Applicator is manufactured from liguid silicone rubber and contains between three and twenty-four embedded hollow tubes. The tubes are spaced 1 cm on center laterally and are positioned 5mm from the treatment surface.
Intended Use: The H.A.M. Applicator is intended to be used as an accessory to highdose-rate (HDR) remote controlled radionuclide applicator systems cleared for market by the FDA. The H.A.M. Applicator may be used externally, on the surface of the patient, to treat superficial tumors or placed internally to treat the tumor or tumor bed in a procedure known as Intraoperative High-Dose-Rate Brachytherapy (IOHDR) [a subset of Intraoperative Radiation Therapy (IORT)], during the time the treatment site is exposed surgically.
Technological Characteristics: The technological characteristics of the H.A.M. Applicator and the predicate device are the same in that both are meant to position radioactive sources in a specific, known geometrical relationship to the treatment volume as prescribed by the physician.
Prepared by: Felix W. Mick, President Mick Radio-Nuclear Instruments, Inc. P.O. Box 99 1470 Outlook Avenue Bronx, NY 10465 Tel: 718-597-3999 Fax: 718-824-8834
Date: 22 September 1996