(94 days)
Not Found
No
The summary describes a radioactive source for brachytherapy and does not mention any AI or ML components.
Yes
The device is indicated for treating localized tumors and involves the direct application of radiation for therapeutic purposes.
No
The device description clearly states its purpose is for treatment ("for the treatment of cancer and other lesions"), not for diagnosis.
No
The device description clearly states it is a physical radioactive source (192Iridium pellet sealed in a stainless steel capsule attached to a cable) used in conjunction with a remote afterloader system. This 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 device is used for the treatment of localized tumors through radiation therapy. IVDs are used for the diagnosis or monitoring of diseases or conditions.
- Device Description: The device is a radioactive source used in brachytherapy, a form of radiation therapy. It does not involve testing samples from the human body (like blood, urine, or tissue) which is characteristic of IVDs.
- Lack of IVD Keywords: The description does not contain any terms typically associated with IVDs, such as "diagnosis," "detection," "measurement," "analysis," "sample," "reagent," etc.
This device falls under the category of a therapeutic medical device, specifically a radiation therapy source.
N/A
Intended Use / Indications for Use
The intended use of Oncology Systems, Inc. Model ACU-007S Brachytherapy Source is for the treatment of cancer and other lesions by temporary interstitial, intracavitary, intraluminal, intraoperative or surface irradiation.
Oncology Systems Model ACU-007S Source Assembly, with an individual activity up to 12Ci, is indicated for temporary interstitial, intracavitary, intraluminal or intraoperative or surface application to treat selected localized tumors. This source can be used as primary treatment for a variety of anatomical sites commonly treated with high dose rate brachytherapy, including the cervix, vagina, endometrium, rectum, esophagus, head and neck, bile duct brain, skin, prostate, lung, pancreas, and breast and for treatment of sarcomas and for intraoperative radiation therapy.
This source may be used concurrently with or following treatment with other interventions, such as external beam radiation therapy, or chemotherapy.
Product codes (comma separated list FDA assigned to the subject device)
KXK
Device Description
Oncology Systems, Inc. Model ACU-007S is a singly-encapsulated 192Iridium Brachytherapy Source. It consists of a single solid radioactive 192 Iridium pellet sealed in a stainless steel capsule that is attached to a cable. Its purpose is to permit manipulation by the Oncology Systems, Inc AccuSource 1000 remote afterloader system for the treatment of cancer and other lesions.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervix, vagina, endometrium, rectum, esophagus, head and neck, bile duct brain, skin, prostate, lung, pancreas, and breast
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): 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.
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
Image /page/0/Picture/1 description: The image shows the logo for Oncology Systems. The logo consists of a four-circle design on the left, with three of the circles patterned and one solid black. To the right of the circles, the words "Oncology Systems" are written in a bold, sans-serif font, with "Oncology" on the top line and "Systems" on the bottom line.
206 N. Randolph Street, Suite 301 Champaign, IL 61820
NOV 2 0 2009
Section 5 510(k) Summary
Section 807.92(a)
| (1) Submitter | Oncology Systems, Inc. | Tel: | 217-355-4460 |
|---|---|---|---|
| 206 N. Randolph Suite 301 | Fax: | 217-355-4470 | |
| Champaign, IL 61820 | |||
| Establishment Registration No.: | SBD096102 | ||
| Contact Person: | Jennifer Williams | ||
| FDA Official Regulatory Correspondent | |||
| e-mail: jwilliams@oncosys.net | |||
| Date Summary Prepared: | 03/27/09 | ||
| (2) | Device Name: | ACU-007S | |
| Common or Usual Name: | Brachytherapy Source Assembly | ||
| Classification Name: | Source Wire, Iridium Radioactive (21CFR 892.5730;PC;IWA;KXK) | ||
| Proprietary Name: | Oncology Systems, Inc. Model ACU-007S |
-
Legally Marketed Predicate Devices: (3)
Source Production and Equipment Company Model M-19, 510(k) number K052947 dated 19 April 2006 -
Description of Oncology Systems, Inc. Model ACU-007S 199ridium Brachytherapy Source: (4)
Oncology Systems, Inc. Model ACU-007S is a singly-encapsulated 1921ridium Brachytherapy Source. It consists of a single solid radioactive 192 ridium pellet sealed in a stainless steel capsule that is attached to a cable. Its purpose is to permit manipulation by the Oncology Systems, Inc AccuSource 1000 remote afterloader system for the treatment of cancer and other lesions. -
Intended Use (5)
The intended use of Oncology Systems, Inc. Model ACU-007S Brachytherapy Source is for the treatment of cancer and other lesions by temporary interstitial, intracavitary, intraluminal, intraoperative or surface irradiation.
1
Image /page/1/Picture/0 description: The image shows the logo for Oncology Systems. The logo consists of four circles on the left, three of which are patterned and one of which is solid black. To the right of the circles is the text "ONCOLOGY SYSTEMS" in a sans-serif font. The word "ONCOLOGY" is above the word "SYSTEMS".
206 N. Randolph Street, Suite 301 Champaign, IL 61820
Technological Characteristics: (6)
Oncology Systems, Inc, Model ACU-007S 19eridium Brachytherapy Source is similar to the predicate high dose rate brachytherapy source, the Source Production and Equipment Company Model M-19 (K052947) that utilizes photons from 182 ridium. See Sections 12.1 Comparison Table with Predicate Device (Similarities and Differences) and section 12.2 Product Information for Predicate Device.
2
Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with three stripes forming its body and wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Ms. Jennifer Williams Official Regulatory Correspondent Oncology Systems, Inc. 206 N. Randolph Street, Suite 301 CHAMPAIGN IL 61820
NOV 2 0 2009
Re: K092522
Trade/Device Name: Oncology Systems, Inc. Model ACU-007S 192 Iridium Brachytherapy Source
Regulation Number: 21 CFR 892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: II Product Code: KXK Dated: August 13, 2009 Received: August 31, 2009
Dear Ms. Williams:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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 of medical
3
Page 2 -
Enclosure
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Janine M. Morris
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
4
Image /page/4/Picture/0 description: The image shows the logo for Oncology Systems. The logo consists of four circles arranged in a square pattern on the left side. To the right of the circles, the words "ONCOLOGY SYSTEMS" are written in a bold, sans-serif font.
206 N. Randolph Street, Suite 301 Champaign, IL 61820
510(k) Number (if known): _
Device Name: Oncology Systems, Inc. Model ACU-007S 19eridium Brachytherapy Source
Indications for Use:
Oncology Systems Model ACU-007S Source Assembly, with an individual activity up to 12Ci, is indicated for temporary interstitial, intracavitary, intraluminal or intraoperative or surface application to treat selected localized tumors. This source can be used as primary treatment for a variety of anatomical sites commonly treated with high dose rate brachytherapy, including the cervix, vagina, endometrium, rectum, esophagus, head and neck, bile duct brain, skin, prostate, lung, pancreas, and breast and for treatment of sarcomas and for intraoperative radiation therapy.
This source may be used concurrently with or following treatment with other interventions, such as external beam radiation therapy, or chemotherapy.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | X | OR |
|---|---|---|
| (Per 21 CFR 801 Subpart D) |
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
| 510(k) Number | K092522 |
|---|---|
| --------------- | --------- |
Over-The-Counter Use _ (Per 21 CFR 801 Subpart C)
(Optional Format 1-2-96)