(14 days)
The Cianna S1, Single Lumen Balloon Applicator is intended to provide brachytherapy when the physician chooses to deliver intracavitary radiation to the surgical margins following lumpectomy for breast cancer.
The Cianna S1 Single Lumen Balloon Applicator is a specialized applicator that is temporarily inserted into the target volume to facilitate the application of radiation to the target site in the treatment of carcinoma. The Cianna S1 Single Lumen Balloon Applicator is provided sterile for single use and is disposable.
The provided text describes the Cianna S1, Single Lumen Balloon Applicator, a medical device for brachytherapy. However, the text does not contain information about a study that assesses the device's performance against specific acceptance criteria in the context of an AI/ML context.
The document is a 510(k) summary for a medical device, which focuses on demonstrating substantial equivalence to a predicate device, not on presenting detailed performance studies with acceptance criteria in the way a clinical or AI/ML performance study would.
Here's a breakdown of what is provided and what is missing based on your request:
Acceptance Criteria and Reported Device Performance
The provided text states: "Performance testing was conducted to evaluate and characterize the performance of the Cianna S1 Single Lumen Balloon Applicator. Preclinical testing conducted included valve and syringe stability, balloon inflation diameter assessment, afterloader compatibility, closed system verification and biocompatibility testing per ISO 10993-1. The Cianna S1 Single Lumen Balloon Applicator performed as intended and met all acceptance criteria."
This is a general statement. Specific acceptance criteria (thresholds or metrics) and the detailed results demonstrating how those criteria were met are NOT provided in the text. For example, it doesn't specify what the acceptable range for "balloon inflation diameter" was, nor the actual measured diameter.
| Acceptance Criteria (Specifics Not Provided) | Reported Device Performance |
|---|---|
| Valve and syringe stability | Performed as intended |
| Balloon inflation diameter assessment | Performed as intended |
| Afterloader compatibility | Performed as intended |
| Closed system verification | Performed as intended |
| Biocompatibility (per ISO 10993-1) | Performed as intended |
Information NOT available in the provided text, as it pertains to AI/ML or detailed clinical study specifics:
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as this is neither an AI/ML device nor a clinical trial report with a test set of patient data. The "testing" mentioned refers to engineering and biocompatibility checks.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method (e.g. 2+1, 3+1, none) 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, as this is not an AI-assisted device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
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K103215 Cianna S1, Single Lumen Balloon Applicator 510(k) A1 Page 8 of 14 510(k) Summary Section 6
1. 510(k) Summary (Revised 10-28-2010)
This 510(k) summary information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| APPLICANT: | Cianna Medical |
|---|---|
| TRADE NAME: | Cianna S1, SINGLE LUMEN BALLOON APPLICATOR |
| COMMON NAME: | Brachytherapy Applicator |
| CLASSIFICATIONNAME: | Remote Controlled Radionuclide Applicator System, 21 CFR892.5700 |
| DEVICECLASSIFICATION: | Class II |
| PRODUCT CODE | JAQ |
PREDICATE DEVICES: Mammosite Radiation Therapy System (K041929)
Substantially Equivalent To:
The Cianna S1 Single Lumen Balloon Applicator is substantially equivalent in intended use, principal of operation and technological characteristics to the Mammosite Radiation Therapy System (K041929).
Description of the Device Subject to Premarket Notification:
The Cianna S1 Single Lumen Balloon Applicator is a specialized applicator that is temporarily inserted into the target volume to facilitate the application of radiation to the target site in the treatment of carcinoma.
The Cianna S1 Single Lumen Balloon Applicator is provided sterile for single use and is disposable.
Indication for Use:
The Cianna S1, Single Lumen Balloon Applicator is intended to provide brachytherapy when the physician chooses to deliver intracavitary radiation to the surgical margins following lumpectomy for breast cancer.
Technical Characteristics:
The Cianna S1 Single Lumen Balloon Applicator has similar physical and technical characteristics to the predicate devices. The Cianna S1 Single Lumen Balloon Applicator
NOV 1 5 2010
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Section 6
and the identified predicates all provide a catheter configuration to allow delivery of radioactive sources in a specific, known geometry, as prescribed by the clinician.
Performance Data:
Performance testing was conducted to evaluate and characterize the performance of the Cianna S1 Single Lumen Balloon Applicator. Preclinical testing conducted included valve and syringe stability, balloon inflation diameter assessment, afterloader compatibility, closed system verification and biocompatibility testing per ISO 10993-1. The Cianna S1 Single Lumen Balloon Applicator performed as intended and met all acceptance criteria.
Basis for Determination of Substantial Equivalence:
The Cianna S1 Single Lumen Balloon Applicator has the following similarities to the predicate device:
- . Same intended use
- . Same design
- . Same operating principal
- Same mechanism of action ●
- Same technological characteristics ●
Upon reviewing the safety and efficacy information provided in this submission and comparing intended use, principle of operation and overall technological characteristics, the Cianna S1 Single Lumen Balloon Applicator is determined by Cianna Medical, to be substantially equivalent to existing existing legally marketed devices.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three wing-like shapes, suggesting movement or flight.
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
Cianna Medical % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
NOV 1 5 2010
Re: K103215
Trade/Device Name: Cianna S1, Single Lumen Balloon Applicator Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator system Regulatory Class: II Product Code: JAQ Dated: October 29, 2010 Received: November 1, 2010
Dear Mr. Job:
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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, . Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting of .
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/cdrh/industry/support/index.html.
Sincerely yours,
Dan
David G. Brown, Ph.D. Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Cianna S1, Single Lumen Balloon Applicator 510(k) A1 Page 6 of 14
INDICATIONS FOR USE STATEMENT
NOV 15 2010
510(k) Number (if known):
Device Name: Cianna S1, Single Lumen Balloon Applicator
Indications for Use:
The Cianna S1, Single Lumen Balloon Applicator is intended to provide
brachytherapy when the physician chooses to deliver intracavitary radiation to the
surgical margins following lumpectomy for breast cancer.
| Labels | Values |
|---|---|
| Prescription Use | X |
| (Per 21 CFR 801.109) | |
| Over-The-Counter Use | |
| (Optional Format 1-2-96) |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
2
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K103215
Page of
§ 892.5700 Remote controlled radionuclide applicator system.
(a)
Identification. A remote controlled radionuclide applicator system is an electromechanical or pneumatic device intended to enable an operator to apply, by remote control, a radionuclide source into the body or to the surface of the body for radiation therapy. This generic type of device may include patient and equipment supports, component parts, treatment planning computer programs, and accessories.(b)
Classification. Class II.