(107 days)
No
The summary describes a physical brachytherapy source and its material composition and intended use, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes.
The device is indicated for treatment of tumors, which is a therapeutic purpose.
No
Explanation: The device description and intended use clearly state that this device is a brachytherapy source used for "treatment" of tumors, not for diagnosis.
No
The device description clearly states it is a "flat flexible planar radioactive 32Phosphorus polymeric film" and describes its physical composition and dimensions. This indicates it is a physical medical device containing a radioactive material, not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Description: The provided text describes a brachytherapy source containing a radioactive isotope (32Phosphorus). This device is designed to be implanted or placed directly on or near a tumor to deliver radiation therapy.
- Intended Use: The intended use is for the treatment of tumors through radiation, not for testing or analyzing biological samples.
The device is a therapeutic device, specifically a brachytherapy source, used for delivering radiation directly to a treatment site. It does not involve the analysis of in vitro specimens.
N/A
Intended Use / Indications for Use
The intended use of RIC Conformal Source Model 100 Brachytherapy Source is for the treatment of cancer by temporary intraoperative or surface irradiation.
RIC Conformal Source Model 100 Brachytherapy Source, containing 32Phosphorus with activity up to 200 mCi is indicated for treatment of cancer by temporary intraoperative, interstitial, intracavitary or surface application to treat residual disease after excision of primary or recurrent tumors. It can be used either as primary treatment or as treatment for re-irradiation and may be administered concurrently with or following treatment with other interventions, such as external beam therapy. Chordomas, chondrosarcomas, soft tissue sarcomas, Skin Cancers and other malignant tumors could be commonly treated by the RIC Conformal Source Model 100 Brachytherapy Source, containing 32Phosphorus.
Product codes
KXK, ONL
Device Description
RIC Conformal Source Model 100 Brachytherapy Source is designed for use in medical Brachytherapy applications. The capacity of each source is up to 200 millicuries of 32Phosphorus. The physician could prescribe a physical size up to 50mm by 100mm.
This RIC Conformal Source is a flat flexible planar radioactive 32Phosphorus polymeric film that could be made conformal to different surface geometries such as flat, concave or convex semi-cylindrical shapes through the use of an appropriately shaped shield / holder or by placement on an area to be treated and made conformal by the weight of a flexible compliant media. At the option of the prescribing physician, the RIC Conformal Source could be attached to a manual radionuclide applicator (available from RI Consultants, Class I device, 892.5650) to facilitate handling and to provide shielding to the clinician.
The RIC Conformal Source consists of 32Phosphorus chemically bound to the biocompatible polymeric film. The polymeric film thickness is 0.3mm (0.012 inch) to 0.7 mm (0.028 inch). The 32Phosphorus polymeric film is then coated with a flexible biocompatible silicone coating which is about 0.01 mm (0.0005 inch) thick.
The 32Phosphorus is chemically bonded to the polymer molecule and is an integral part of the film.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 description: The image shows the logo for RI Consultants LLC. The logo consists of a stylized atom symbol to the left of the text "RI Consultants LLC". The atom symbol is made up of three overlapping ellipses and three lines that intersect at the center.
K09032 Section 5 510(k) Summary
MAY 27 2009
Section 807.92(a)
(1) : Submitter
Tel: RI Consultants LLC Fax: Pinanski 202, UML PO Box 1856 Lowell, MA 01854
603.247.1423 603.882.1912
Establishment Registration No : Not yet applied for in accordance with 21CFR 807.21
Contact Person:
Thomas Golembeski Director e-mail: tgolembeski@risotopes.com
- Device Name: (2)
.
Radionuclide Brachytherapy Source (892.5730) (90 KXK) Classification Name: Brachytherapy Source Common or Usual Name: RIC Conformal Source Model 100 Proprietary Name:
- Legally Marketed Predicate Devices: (3)
BEBIG Plaques RUM101-RUM114 K931393 dated 16 March 1994, and
New England Nuclear 90 Strontium NB-1 Eve Applicator Pre-Amendment Device
- Description of RIC Conformal Source Model 100: (4)
RIC Conformal Source Model 100 Brachytherapy Source is designed for use in medical Brachytherapy applications. The capacity of each source is up to 200 millicuries of 32Phosphorus. The physician could prescribe a physical size up to 50mm by 100mm.
This RIC Conformal Source is a flat flexible planar radioactive 32Phosphorus polymeric film that could be made conformal to different surface geometries such as flat, concave or convex semi-cvlindrical shapes through the use of an appropriately shaped shield / holder or by placement on an area to be treated and made conformal by the weight of a flexible compliant media. At the option of the prescribing physician, the RIC Conformal Source could be attached to a manual radionuclide applicator (available from RI
1
Image /page/1/Picture/0 description: The image shows the logo for "RI Consultants LLC". To the left of the text is an atom-like symbol. The text is in bold.
Consultants, Class I device, 892.5650) to facilitate handling and to provide shielding to the clinician.
The RIC Conformal Source consists of 32Phosphorus chemically bound to the biocompatible polymeric film. The polymeric film thickness is 0.3mm (0.012 inch) to 0.7 mm (0.028 inch). The 32Phosphorus polymeric film is then coated with a flexible biocompatible silicone coating which is about 0.01 mm (0.0005 inch) thick.
The 32Phosphorus is chemically bonded to the polymer molecule and is an integral part of the film.
-
(5) Intended Use
The intended use of RIC Conformal Source Model 100 Brachytherapy Source is for the treatment of cancer by temporary intraoperative or surface irradiation. -
(6) Technological Characteristics:
RIC Conformal Source Model 100 Brachytherapy Source is similar to the predicate brachytherapy source, BEBIG Plaques RUM101-RUM114, K931393 dated 16 March 1994, and New England Nuclear 90 Strontium NB-1 Eye Applicator, Pre-Amendment Device, that utilizes ß particles from 90Yttrium.
The RIC Conformal Source Model 100 Brachytherapy Source is provided non-sterile.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract emblem resembling an eagle or bird in flight, composed of three curved lines.
Public Health Service
MAY 2 7 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Thomas Golembeski Director RI Consultants LLC 1 Chagnon Lane HUDSON NH 03051
Re: K090321
Trade/Device Name: RIC Conformal Source Model 100 Brachytherapy Source Regulation Number: 21 CFR 892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: II Product Code: ONL, KXK Dated: April 14, 2009 Received: April 22, 2009
Dear Mr. Golembeski:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications 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) that do not require approval of a premarket approval application (PMA). 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.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
21 CFR 876.xxx (Gastroenterology/Renal/Urology) (240) 276-0115 (Obstetrics/Gynecology) (240) 276-0115 21 CFR 884.xxx (240) 276-0120 21 CFR 892.xxx (Radiology) (240) 276-0100 Other
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely wours. unite
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number K090321
Device Name: RIC Conformal Source Model 100 Brachytherapy Source
Indications for Use:
RIC Conformal Source Model 100 Brachytherapy Source, containing 32Phosphorus with activity റിയ Conformat Godroo Model 190 Brach finensporary intraoperative, interstitial, intracavitary or up to 200 mOTis indivated for treatmont on the control. It can be used either as primary surrace application to trout offer excision of primary or recurrent tumors. treatment of as troutinent for recharacted concurrently with or following treatment with other interventions, such as external beam therapy. Chordomas, chondrosarcomas, soft tissue interventions, out as excernatible tumors could be commonly treated by the RIC Sarcomas, Skin Jansers and Citierapy Source, containing 32Phosphorus.
(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
(Optional Format 1-2-96)
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Device 510(k) Number