(68 days)
Not Found
No
The 510(k) summary describes a radioactive brachytherapy source and does not mention any AI or ML components or functionalities.
Yes
The device is used to treat localized tumors, which is a therapeutic purpose.
No
Explanation: The device description clearly states its purpose is for "temporary or permanent interstitial, intracavitary, intraluminal or intraoperative implantation or surface application to treat selected localized tumors." This indicates a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a "singly-encapsulated 18° vtterbium Brachytherapy Source" consisting of a "titanium capsule containing a solid radioactive 19° tterbium pellet." This describes a physical, hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring or compatibility purposes.
- Device Description and Intended Use: The provided text clearly describes a brachytherapy source used for treating localized tumors through radiation. This is an in vivo treatment, meaning it is applied directly to the patient's body, not used to test samples outside the body.
The device's function is therapeutic (delivering radiation to treat cancer), not diagnostic (analyzing samples to identify a condition).
N/A
Intended Use / Indications for Use
The intended use of SPEC Model M-31 Brachytherapy Source is for the treatment of cancer by temporary or permanent interstitial, intracavitary, intraluminal or intraoperative implantation or surface application.
Source Production & Equipment Cc., Inc. (SPEC) Model M-31 169 Ytterbium Brachytherapy Sources, with individual activities up to 5 mCi (185 MBq), are indicated for temporary or permanent interstitial. intracavitary, intraluminal or intraoperative implantation or surface application to treat selected localized tumors. They can be used either as primary treatment for unresectable tumors, or as treatment for residual disease after excision of primary or recurrent tumors such as for lung cancer. Model M-31 Brachytherapy Source may be used concurrently with or following treatment with other interventions, such as external beam therapy, or chemotherapy. Tumors of the head, neck, lung, pancreas, prostate, breast and other accessible tumors are commonly treated.
Product codes
KXK
Device Description
SPEC Model M-31 is a singly-encapsulated 169 Ytterbium Brachytherapy Source. It consists of a titanium capsule containing a solid radioactive 169 Ytterbium pellet. The capsule encasing the pellet consists of a titanium tube which is closed on each end with titanium wires which are laser-welded to the tubing.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tumors of the head, neck, lung, pancreas, prostate, breast and other accessible tumors are commonly treated.
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
K09C36L
Image /page/0/Picture/1 description: The image shows the word "spec" in a bold, sans-serif font. To the right of the word "spec" is a radiation symbol. The word "spec" and the radiation symbol are both outlined in black.
APR 2 2 2009
Section 5 510(k) Summarv
Section 807.92(a)
Submitter Source Production & Equipment Co., Inc. (1) Tel: 504.464.9471 113 Teal Street Fax: 504.467.7685 St. Rose, LA 70087
Establishment Registration No .: 1000437833
John J. Munro III Contact Person:
Vice President e-mail: johnm@spec150.com
-
(2) Device Name:
Radionuclide Brachytherapy Source (892.5730) (90 KXK) Classification Name: Common or Usual Name: Brachytherapy Source Proprietary Name: SPEC Model M-31 -
(3) Legally Marketed Predicate Devices:
Implant Sciences I-Plant Model 3500 (125)odine Brachytherapy Seed), cleared under 510(k) number K994317 dated 21 March 2000, and
Implant Sciences Corp. HDR 4140 168 Ytterbium High Dose Rate Brachytherapy Source, cleared under 510(k) number K042864 dated 06 January 2005
-
Description of SPEC Model M-31 169 Ytterbium Brachytherapy Source: (4)
SPEC Model M-31 is a singly-encapsulated 18° vtterbium Brachytherapy Source. It consists of a
titanium capsule containing a solid radioactive 19° tterbium pellet. The capsu the pellet consists of a titanium tube which is closed on each end with titanium wires which are laser-welded to the tubing. -
Intended Use (5)
The intended use of SPEC Model M-31 Brachytherapy Source is for the treatment of cancer by temporary or permanent interstitial, intracavitary, intraluminal or intraoperative implantation or surface application. -
(6) Technological Characteristics:
SPEC Model M-31 169 tterbium Brachytherapy Source is similar to the predicate low dose rate brachytherapy source and utilizes photons from 169 Ytterbium.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird in flight, composed of three curved lines. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the bird symbol.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 2 2009
John J. Munro III. Ph.D. Vice President Source Production & Equipment Co., Inc. 113 Teal Street ST. ROSE LA 70087
Re: K090366 .
Trade/Device Name: Model M-31 169 Ytterbium Brachytherapy Source Regulation Number: 21 CFR 892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: II Product Code: KXK Dated: April 14, 2009 Received: April 16, 2009
Dear Dr. Munro:
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.
2
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 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | (240) 276-0115 |
| 21 CFR 892.xxx | (Radiology) | (240) 276-0120 |
| Other | (240) 276-0100 |
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 yours,
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number: K090366
Device Name:
Source Production & Equipment Co., Inc. Model M-31 169Ytterbium Brachytherapy Source
Indications for Use:
Source Production & Equipment Cc., Inc. (SPEC) Model M-31 198 Ytterbium Brachytherapy Sources, with individual activities up to 5 mCi (185 MBq), are indicated for temporary or permanent interstitial. intracavitary, intraluminal or intraoperative implantation or surface application to treat selected localized tumors. They can be used either as primary treatment for unresectable tumors, or as treatment for residual disease after excision of primary or recurrent tumors such as for lung cancer. Model M-31 Brachytherapy Source may be used concurrently with or following treatment with other interventions, such as external beam therapy, or chemotherapy. Tumors of the head, neck, lung, pancreas, prostate, breast 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 X (Per 21 CFR 801.109)
OR
/oom M. Whing
(Division Sign Off)
Division of Reproductive, Abdom and Radiological Dev 510(k) Number
Over-The-Counter Use
(Optional Format 1-2-96)