(15 days)
The Contura Cavity Maintenance Catheter is temporarily implanted in the lumpectomy cavity as a placeholder until it is exchanged for the Contura MLB Applicator.
The Contura Cavity Maintenance Catheter consists of a dual lumen silicone catheter with an inflatable balloon at its distal end. Two proximal ports are provided with Luer-type connectors for balloon inflation/deflation and for application of intracavitary vacuum. The Contura CMC is available in a spherical, 3.5-5.0 cm diameter balloon size.
The provided text describes the 510(k) summary for the SenoRx Contura Cavity Maintenance Catheter. It outlines the device's purpose, its equivalence to a predicate device, and the performance testing conducted. However, it does not contain the specific information requested about acceptance criteria, a study proving device meets acceptance criteria, sample sizes for test/training sets, expert qualifications, ground truth establishment, or details of a multi-reader multi-case study.
The document is a regulatory submission for device clearance, focusing on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed study results against specific acceptance criteria.
Therefore, many of the requested details cannot be extracted from the provided text.
Here's an attempt to populate the table and answer the questions based only on the available information, noting where information is absent:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in the document. The overall implicit acceptance criterion is "substantial equivalence" to the predicate device and that the device "performed as intended." | Dimensional stability of the inflated balloon: Not explicitly detailed, but implied to be acceptable. |
| Burst volume testing: Not explicitly detailed, but implied to be acceptable. | |
| Balloon durability in an in vivo setting: Not explicitly detailed, but implied to be acceptable. | |
| Biocompatibility testing: Not explicitly detailed, but implied to be acceptable. | |
| Device performed "as intended." | |
| Device has "sub-set of the intended uses; same design; same patient contacting material; same operating principle; and same technological characteristics" as the predicate. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for the test set: Not provided.
- Data provenance: Not provided (e.g., country of origin, retrospective/prospective). The testing appears to be preclinical (bench and in vivo), not human clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided. The testing described is preclinical (dimensional stability, burst volume, durability, biocompatibility), which typically does not involve expert consensus for ground truth on clinical images or diagnoses.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. As the testing appears to be preclinical and does not involve human interpretation of clinical data in a diagnostic context, an adjudication method for a test set is not applicable or described.
5. 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
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done or described. This device is a physical medical device (catheter) and not an AI-powered diagnostic tool, so such a study would not be applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone study was not done or described. This device is a physical medical device (catheter) and not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the preclinical tests described (dimensional stability, burst volume, in vivo durability, biocompatibility), the "ground truth" would be established by objective measurements and laboratory standards for physical and material properties, as well as biological responses in an in vivo setting (likely animal models for some aspects of durability/biocompatibility) against predetermined specifications. It's not based on expert clinical consensus, pathology, or outcomes data in the way an AI diagnostic tool would be.
8. The sample size for the training set
This information is not provided. This device is a physical medical device and would not typically have a "training set" in the context of an algorithm or AI.
9. How the ground truth for the training set was established
This information is not provided. As above, the concept of a "training set" and its "ground truth" is not applicable to the preclinical testing of this physical medical device.
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5. 510(K) SUMMARY
Date prepared
July 28, 2009
Name SenoRx, Inc. AUG 1 9 2009 3 Morgan Irvine, CA 92618 T. 949.362.4800; F. 949.362.0300 Contact person Eben Gordon Vice President, RA/QA SenoRx, Inc. T. 949.362.4800; F. 949.362.0300 Device name Contura Cavity Maintenance Catheter Common name Cavity Maintenance Catheter Classification name Remote controlled radionuclide source applicator Classification regulation 21 CFR 892.5700 90 JAQ Predicate devices MammoSite Cavity Evaluation Device, K081179 Clearance date: 5/9/2008 Description The Contura Cavity Maintenance Catheter consists of a dual lumen silicone catheter with an inflatable balloon at its distal end. Two proximal ports are provided with Luer-type connectors for balloon inflation/deflation and for application of intracavitary vacuum. The Contura CMC is available in a spherical, 3.5-5.0 cm diameter balloon size. Indications for use The Contura Cavity Maintenance Catheter is temporarily implanted in the lumpectomy cavity as a placeholder until it is exchanged for the Contura MLB Applicator. Summary of substantial Performance testing was conducted to evaluate and characterize the equivalence performance of the Contura Cavity Maintenance Catheter. Preclinical testing conducted included dimensional stability of the inflated balloon, burst volume testing, balloon durability in an in vivo setting, and biocompatibility testing. The Contura Cavity Maintenance Catheter performed as intended. The Contura Cavity Maintenance Catheter has the following similarities to the predicate device in that it: has a sub-set of the intended uses; same design; same patient contacting material; same operating principle; and same technological characteristics. The Contura Cavity Maintenance Catheter is substantially equivalent predicate device when used as a placeholder until it is exchanged for a brachytherapy applicator (e.g. Contura MLB Applicator).
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Image /page/1/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name arranged in a circular pattern around the perimeter. In the center of the seal is a stylized representation of a caduceus, a symbol often associated with medicine and healthcare.
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
SenoRx, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
AUG 1 9 2009
Re: K092323
Trade/Device Name: Contura Cavity Maintenance Catheter Regulation Number: 21 CFR 892.5700 Regulation Name: Radiation therapy beam-shaping block Regulatory Class: II Product Code: JAQ Dated: July 31, 2009 Received: August 4, 2009
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 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 vour 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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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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sammy M. Morris
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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4. INDICATIONS FOR USE
510(k) Number (if known): (५०५2323
Device Name: Contura Cavity Maintenance Catheter
Indications for Use:
The Contura Cavity Maintenance Catheter is temporarily implanted in the lumpectomy cavity as a placeholder until it is exchanged for the Contura MLB Applicator.
Prescription Use ਮ (Part 21 CFR 801 Subpart D) AND/OR
Over the Counter Use
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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(Division Sign-O in Division of Reproductive, Abdominal, and Radiological Device 510(k) Number_
Page of 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.