(94 days)
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.
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.
The provided text is a 510(k) summary for the Oncology Systems, Inc. Model ACU-007S 192 Iridium Brachytherapy Source. This document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study proving a device meets specific acceptance criteria based on performance metrics like sensitivity, specificity, or image quality, which are common for diagnostic or AI-powered devices.
As this is a brachytherapy source, the "acceptance criteria" and "study" described in the prompt are not applicable in the way they would be for a diagnostic or AI device. The submission focuses on physical and technical characteristics, intended use, and equivalence to a legally marketed predicate device.
Therefore, the following information cannot be extracted from the provided text:
- A table of acceptance criteria and the reported device performance: This type of performance data (e.g., sensitivity, specificity, accuracy) is not included in the document for a brachytherapy source. The "performance" here relates to its functional characteristics and safety, which are implicitly accepted by demonstrating substantial equivalence.
- Sample sizes used for the test set and the data provenance: Not applicable. There is no "test set" in the context of diagnostic performance evaluation.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth determination study is described.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is not an AI-powered diagnostic tool.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
What the document does provide:
The document primarily focuses on establishing substantial equivalence to a predicate device (Source Production and Equipment Company Model M-19, K052947). This is the key "acceptance criterion" for a 510(k) submission of this type.
Key information provided related to "acceptance" for this type of device:
- Intended Use: The device is intended for the treatment of cancer and other lesions by temporary interstitial, intracavitary, intraluminal, intraoperative or surface irradiation. This is a critical aspect for regulatory acceptance.
- Technological Characteristics: The device is described as a singly-encapsulated 192Iridium Brachytherapy Source consisting of a single solid radioactive 192Iridium pellet sealed in a stainless steel capsule attached to a cable. Its similarity to the predicate device (Source Production and Equipment Company Model M-19) in utilizing photons from 192Iridium is highlighted as the basis for substantial equivalence.
- Predicate Device Comparison: Section 12.1 (mentioned but not included in this extract) would detail the comparison of similarities and differences with the predicate device. This comparison forms the "study" demonstrating that the new device is as safe and effective as the predicate.
- Regulatory Classification: The device is classified under 21 CFR 892.5730 as a Radionuclide brachytherapy source, Regulatory Class II, Product Code KXK. This classification dictates the regulatory pathway for acceptance.
In summary, for K092522, the "acceptance criteria" are met by demonstrating substantial equivalence to a legally marketed predicate device, primarily through comparison of its design, materials, and intended use, rather than through a clinical performance study with statistical metrics.
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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.
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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.
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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
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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
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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)
§ 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.