(204 days)
Not Found
No
The summary describes a radioactive source for brachytherapy and its physical characteristics, manufacturing, and testing. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes.
Explanation: The device is indicated for temporary or permanent interstitial implantation or surface application to treat selected localized tumors, either as primary treatment or for residual disease after excision, clearly aligning with the definition of a therapeutic device.
No
Explanation: The device is described as a source for brachytherapy, which is a treatment modality for cancer, not a diagnostic tool. Its intended use is to treat localized tumors through interstitial implantation or surface application of radioactive material.
No
The device description clearly states it is a physical object in the form of a coiled rhodium wire containing a radionuclide (Pd-103) for brachytherapy. It is manufactured, packaged, and sterilized as a physical medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the treatment of localized tumors through interstitial implantation or surface application of a radioactive source. This is a therapeutic intervention performed in vivo (within the body).
- Device Description: The device is a sealed radioactive source (Pd-103) in the form of a wire, used for brachytherapy. This is a medical device used for treatment, not for diagnostic testing of samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on biological samples in vitro. This device is a therapeutic device used directly on the patient's body.
N/A
Intended Use / Indications for Use
The RadioMed™ Source with activities from 0.1 to 5.0 mCi per centimeter length is indicated for temporary or permanent interstitial implantation or surface application to treat selected localized turnors. They can be used as either primary treatment or as treatment for residual disease after excision of primary or recurrent tumors. The RadioMed M Source may be used concurrently with or following treatment with other interventions. such as external beam therapy, hyperthermia, or chemotherapy. Tumors of the head, neck, lung, pancreas, prostate and other accessible tumors are commonly treated.
The RadioMed™ Source with activities from 0.1 to 5.0mCi per centimeter is indicated for temporary or permanent interstitial implantation or surface application to treat selected localized turnors. They can be used either as primary treatment (such as for prostate cancer or unresectable tumors) or as treatment for residual disease after excision of primary or recurrent tumors. The Pd-103 sources may be used concurrently with or following treatment with other interventions, such as external beam therapy, hyperthermia, or chemotherapy. Tumors of the head, neck, lung, pancreas, prostate and other accessible tumors are commonly treated.
Product codes (comma separated list FDA assigned to the subject device)
90 KXK
Device Description
The RadioMed™ source utilizes Pd-103 as the radionuclide for brachytherapy. The RadioMed The Source exists in the form of a coiled rhodium wire. The rhodium matrix also provides the radiopacity of the device. The RadioMed™ Source is a naturally sealed source in the form of a wire.
The RadioMed The Source is packaged non-sterile, single use, and is intended to be sterilized by the end user in accordance with a validated sterilization process. Sterilization is accomplished by exposure to steam autoclave.
The RadioMed" Source will be manufactured. labeled and packaged under GMP controls. Upon completion of the manufacturing and assembly process the device will be inspected to assure compliance to specifications. The devices will be tested in accordance with Standard Operating Procedures.
The sources are delivered in the same manner as brachytherapy seeds currently on the market, i.e. a 17 or 18-gauge needle and stylet.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
head, neck, lung, pancreas, prostate and other accessible tumors
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The "performance" of the RadioMed™ source is subdivided into four categories
- Radiation Energy
- Source Strength Measurement: Calibration and Calibration Accuracy
- Dose Comparison
- Sealed Source Testing
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Theragenics Pd-103 Seed K874787, Medi-Physics Rapid Strand TM K940632, Ir-192 Wires from Amersham International - Preammendments device
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.5730 Radionuclide brachytherapy source.
(a)
Identification. A radionuclide brachytherapy source is a device that consists of a radionuclide which may be enclosed in a sealed container made of gold, titanium, stainless steel, or platinum and intended for medical purposes to be placed onto a body surface or into a body cavity or tissue as a source of nuclear radiation for therapy.(b)
Classification. Class II (special controls). A prostate seeding kit intended for use with a radionuclide brachytherapy source only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
RadioMed Corporation March 31, 2000
OCT 2 4 2000
Lone
RadioMed™ Source Premarket Notification
RadioMed Corporation 9 Linnell Circle Billerica. MA 01821-3902
510k Summary
- Sponsor Name
RadioMed Corporation 9 Linnell Circle Billerica, Massachusetts 01821-3902
Telephone:
(978) 663-7400 voice (978) 663-7771 fax
Contact Individual: John Schwamb
-
- Device Name
Proprietary Name: Common/Usual Name: Classification Name:
- Device Name
RadioMed™ Source Brachytherapy Radionuclide Source Brachytherapy Radionuclide
4. Device Description
The RadioMed™ source utilizes Pd-103 as the radionuclide for brachytherapy. The RadioMed The Source exists in the form of a coiled rhodium wire. The rhodium matrix also provides the radiopacity of the device. The RadioMed™ Source is a naturally sealed source in the form of a wire.
The RadioMed The Source is packaged non-sterile, single use, and is intended to be sterilized by the end user in accordance with a validated sterilization process. Sterilization is accomplished by exposure to steam autoclave.
The RadioMed" Source will be manufactured. labeled and packaged under GMP controls. Upon completion of the manufacturing and assembly process the device will be inspected to assure compliance to
1
RadioMed Corporation March 31, 2000
RadioMed™ Source
Premarket Notification
10081620
Page 2 of 3
7 Performance Testing
Summary of standards achieved:
FDA QSR 21 CFR Part 820 Good Manufacturing Practices ISO 10993-1 1992 (E) Biological Evaluation of Medical Devices ANSI N43.6-1997: Classification of sealed radioactive sources ANSI N44.1-1973 Integrity and Test Specifications for selected Brachytherapy Sources ANSI N44.2-1973 Leak testing radioactive brachytherapy sources ISO 9978: 1992(E) "Radiation protection - Sealed radioactive sources - Leakage test methods".
AAMI Standard 11134-1994 Recommended practice for Steam Autoclave
The "performance" of the RadioMed™ source is subdivided into four categories
-
- Radiation Energy
-
- Source Strength Measurement: Calibration and Calibration Accuracy
-
- Dose Comparison
-
- Sealed Source Testing
2
specifications. The devices will be tested in accordance with Standard Operating Procedures.
The sources are delivered in the same manner as brachytherapy seeds currently on the market, i.e. a 17 or 18-gauge needle and stylet.
5. Intended Use
The RadioMed" Source with activities from 0.1 to 5.0 mCi per centimeter length is indicated for temporary or permanent interstitial implantation or surface application to treat selected localized turnors. They can be used as either primary treatment or as treatment for residual disease after excision of primary or recurrent tumors. The RadioMed M Source may be used concurrently with or following treatment with other interventions. such as external beam therapy, hyperthermia, or chemotherapy. Tumors of the head, neck, lung, pancreas, prostate and other accessible tumors are commonly treated.
-
- Comparison of Technological Characteristics
The design of each of the predicates and the RadioMed™ Source is a sealed source from which to deliver a therapeutic dosage of radioactive energy. The predicate devices use a sealed source in a "can" configuration, often referred to as a seed. The RadioMed™ Source is a sealed source in the form of a wire. The RadioMed source, like Ir-192 wires, is linear. In contrast, the Theragenics Seed and the I-125 Seeds that are inside of the Rapid Strand 10 are designed to emulate point sources.
- Comparison of Technological Characteristics
The energy emitted for the RadioMed™ Source and the Theragenics 103Pd Seed is exactly the same: 20-23 keV x-rays.
The materials that make up the components of the predicates and the RadioMed The Source are both similar and different. The shells for the predicate devices and the RadioMed "" Source are different. Both predicate seeds use titanium. The RadioMed Source uses rhodium. The radionuclide for the predicate Theragenics 103Pd seed is Palladium - 103 which is the same as the RadioMedith Source. The marker in each of the predicate devices is lead, while that in the RadioMed Source is rhodium.
The delivery of the predicates and the RadioMed" Source is through a 17 or 18-gauge needle and stylet.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 4 2000
John Schwamb Quality Manager RadioMed Corporation 9 Linnell Circle Billerica, MA 01821
Re:
K001070 RadioMed™ Source Dated: August 4, 2000 Received: August 7, 2000 Regulatory class: II 21 CFR 892.5730/Procode: 90 KXK
Dear Mr. Schwamb:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent for use stated in the enclosure) to legally marketed predicate 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 II (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 substantialion assumes compliance with the Current Good Mannfacturing Practice requirements, as set forth in the Ouality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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 submission does not affect any obligation you might have under sections 531 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) 594-4639. 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" (21CFR 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/dsma/dsmamain.html".
Sincerely yours,
The text in the image is:
Baniel G. Schultz, M.D. Captain, USPHS Acting Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure (s)
4
RadioMed Corporation March 31, 2000
RadioMed™ Source Premarket Notification
510(k) Number (if known): K001070
Device Name:
RadioMed™ Source
Indications For Use:
The RadioMed"10 Source with activities from 0.1 to 5.0mCi per centimeter is indicated for temporary or permanent interstitial implantation or surface application to treat selected localized turnors. They can be used either as primary treatment (such as for prostate cancer or unresectable tumors) or as treatment for residual disease after excision of primary or recurrent tumors. The Pd-103 sources may be used concurrently with or following treatment with other interventions, such as external beam therapy, hyperthermia, or chemotherapy. Tumors of the head, neck, lung, pancreas, prostate and other accessible tumors are commonly treated.
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use × (Per 21 CFR 801.109)
OR
Over-The-Counter Use
Simil Ch. Segura
(Division Sign Off) Division of Reproductive, Abdominal, ENT. and Radiological Devices 510(k) Number