(198 days)
Breast Bolster was specifically designed to enable stereotactic breast biopsy procedures to be performed on thin-breasted patients.
Not Found
Analysis of Acceptance Criteria and Study for the Breast Bolster Device
Based on the provided document, the "Breast Bolster" (K020624) is a Class II medical device, and the FDA's decision is a Substantial Equivalence (SE) determination to a legally marketed predicate device. This means the device met acceptance criteria not through a standalone performance study with defined metrics, but by demonstrating that it is as safe and effective as a device already on the market.
Therefore, the requested information categories about direct performance metrics, sample sizes, expert involvement, and ground truth for a diagnostic AI/ML device do not directly apply to this 510(k) submission for the Breast Bolster. The 510(k) process for this type of device focuses on comparison to a predicate, not on a primary clinical performance trial with novel acceptance criteria.
However, I can extract information relevant to the 510(k) process as it relates to acceptance for marketing.
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) for substantial equivalence, the "acceptance criteria" is primarily demonstrating similarity to a predicate device in terms of intended use, technological characteristics, and safety/effectiveness. There are no specific performance metrics like sensitivity or specificity reported in this document.
| Acceptance Criteria (Implied for 510(k) SE) | Reported Device Performance (as per 510(k) process) |
|---|---|
| Intended Use Equivalence: Device's intended use is the same as the predicate. | "Breast Bolster was specifically designed to enable stereotactic breast biopsy procedures to be performed on thin-breasted patients." (This intent would be compared to a predicate device's intended use). |
| Technological Characteristics Equivalence: Device has similar technological characteristics, or any differences do not raise new questions of safety or effectiveness. | Not explicitly detailed in this letter, but would have been part of the full 510(k) submission. This would involve comparing materials, design, mechanism of action, etc. with the predicate. |
| Safety and Effectiveness Equivalence: Device is as safe and effective as the predicate. | Not explicitly detailed in this letter. This would be demonstrated through comparison of non-clinical and/or clinical data with the predicate, or justification that new aspects do not impact safety/effectiveness. |
| Regulatory Compliance: Adherence to general controls and relevant specific controls. | The FDA letter confirms the device can be marketed "subject to the general controls provisions of the Act," and notes that it may be subject to additional controls if classified as Class II. |
Regarding the Study that Proves the Device Meets Acceptance Criteria:
The "study" that proves the device meets acceptance criteria in a 510(k) substantially equivalent submission is the comparison to a legally marketed predicate device.
- The document explicitly states: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... 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..."
The information requested below for a performance study is generally not applicable to this type of 510(k) submission where direct clinical performance metrics are not the primary basis for market clearance.
2. Sample size used for the test set and the data provenance: Not applicable. The 510(k) focused on comparison to a predicate, not an independent test set for performance metrics.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for performance metrics was not established as part of this 510(k) for substantial equivalence.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable. This device is a "Breast Bolster," a physical accessory for mammography, not an AI/ML diagnostic software.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as detailed performance metrics and ground truth are not the basis for this type of 510(k) clearance. The "ground truth" for a 510(k) SE is the established safety and effectiveness of the predicate device.
8. The sample size for the training set: Not applicable. This is a physical device, not an AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established: Not applicable.
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Image /page/0/Picture/0 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES" written around the edge. In the center of the seal is a stylized image of an eagle with its wings spread. The eagle is facing to the left and has three lines representing its body and wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 2 2002
Ms. Maeghan Archambault Breast Biopsy Specialist Beekley Corporation Prestige Lane BRISTOL CT 06010
Re: K020624
Trade/Device Name: Breast Bolster Regulation Number: 21 CFR 892.1710 Regulation Name: Mammographic x-ray system Regulatory Class: II Product Code: 90 IZH Dated: August 5, 2002 Received: August 7, 2002
Dear Ms. Archambault:
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); 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.
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This letter will allow you to begin marketing your device as described in your 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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmaldsmamain.html.
Sincerely yours,
Nancy C. Grigdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| 510(k) Number (if known): | K020624 |
|---|---|
| Device Name: | Breast Bolster |
| Indications For Use: |
Page 2 of 2Breast Bolster was specifically designed to enable stereotactic breast biopsy procedures to be performed on thin-breasted patients.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
2 Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
(
Nancy C. Broadon
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number __
§ 892.1710 Mammographic x-ray system.
(a)
Identification. A mammographic x-ray system is a device intended to be used to produce radiographs of the breast. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.