(22 days)
The Rubicor EnCapsule™ Breast Biopsy Device is intended for diagnostic sampling of breast tissue during breast biopsy procedure. The Rubicor EnCapsule™ Breast Biopsy Device is to be used for diagnostic purposes only and is not intended for therapeutic uses.
Not Found
The provided text describes a 510(k) submission for the Rubicor EnCapsule™ Breast Biopsy Device. This device is classified as an electrosurgical device and accessories (21 CFR 870.4400) and is intended for diagnostic sampling of breast tissue during breast biopsy procedures. The submission is for a device in 2002, and at that time, 510(k) submissions were primarily focused on demonstrating substantial equivalence to a predicate device rather than extensive clinical efficacy studies with specific acceptance criteria and performance metrics as might be seen in later regulations or for higher-risk devices.
Based on the provided text, there is no detailed acceptance criteria or a study proving specific performance metrics in the way modern AI/software device submissions might include. The focus of this 510(k) is on safety and substantial equivalence.
Here's an analysis of the available information against your requested points:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated as quantifiable metrics. The implied acceptance criteria for a 510(k) in 2002 revolve around demonstrating: - Safety and effectiveness - Substantial equivalence to a predicate device | Performance: "Results of in-vitro testing demonstrate that Rubicor EnCapsule™ Breast Biopsy Device is safe and effective for its intended function." Biocompatibility: "The materials used in the Rubicor EnCapsule™ Breast Biopsy Device have been shown to be biocompatible." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified. The document only mentions "in-vitro testing."
- Data Provenance: Not specified.
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)
- Not applicable. The submission focuses on in-vitro testing for a physical biopsy device, not on diagnostic performance where expert ground truth would typically be established for image interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This is not a study assessing diagnostic accuracy requiring adjudication.
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. This is a physical biopsy device, not an AI or imaging diagnostic aid.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is a physical biopsy device, not an AI or software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the "in-vitro testing" and "biocompatibility" mentioned, the ground truth would be based on engineering specifications, laboratory standards, and material science principles rather than clinical outcomes or pathology for diagnostic accuracy. Specific details are not provided.
8. The sample size for the training set
- Not applicable. This is a physical device, not an AI/ML algorithm.
9. How the ground truth for the training set was established
- Not applicable.
Summary of Study (as described in the 510(k)):
The study described is not a clinical study in the sense of evaluating diagnostic performance against a ground truth. Instead, it's a submission demonstrating the safety and effectiveness of a physical medical device (a breast biopsy device) primarily through in-vitro testing and biocompatibility assessments. The core of the 510(k) process is to show substantial equivalence to a predicate device (Rubicor Breast Biopsy Device, K020047). The text only states that the in-vitro testing demonstrated the device is "safe and effective for its intended function" and that its materials are "biocompatible." No specific quantifiable acceptance criteria or detailed study results are provided in this summary.
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510 (k) Summary
This summary of 510(k)-safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
Date Prepared: October 24, 2002
510(k) number:
NOV 1 9 2002
Applicant Information:
Rubicor Medical, Inc. 849 Veterans Blvd. Redwood City, CA 94063
| Contact Person: | Ary Chernomorsky |
|---|---|
| Phone Number: | (650) 556-1070 |
| Fax Number: | (650) 556-1821 |
Device Information:
| Classification: | Class II |
|---|---|
| Trade Name: | Rubicor EnCapsuleTM Breast Biopsy Device |
| Classification Name: | Electrosurgical Device and accessories (21 CFR 870.4400) |
Equivalent Device:
The subject device is substantially equivalent in intended use and/or method of operation to the Rubicor Breast Biopsy Device (K020047)
Intended Use:
The Rubicor EnCapsule™ Breast Biopsy Device is intended for diagnostic sampling of breast tissue during breast biopsy procedure.
The Rubicor EnCapsule™ Breast Biopsy Device is to be used for diagnostic purposes only and is not intended for therapeutic uses.
Test Results:
Performance
Results of in-vitro testing demonstrate that Rubicor EnCapsule™ Breast Biopsy Device is safe and effective for its intended function.
Biocompatibility
The materials used in the Rubicor EnCapsule™ Breast Biopsy Device have been shown to be biocompatible.
Summary:
Based on the intended use, product, performance and biocompatability information provided in this notification, the subject device has been shown to be substantially equivalent to the currently marketed and unmodified predicate device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name arranged in a circular pattern around a central emblem. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three wavy lines representing the serpent entwined around a staff.
Public Health Service
NOV 1 9 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Rubicor Medical. Inc. Robert J. Chin, Ph.D. Regulatory Consultant 849 Veterans Boulevard Redwood City, California 94063
Re: K023601
Trade/Device Name: Rubicor Encapsule Breast Biopsy Device, Model 30086 Regulation Number: 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: October 24, 2002 Received: October 28, 2002
Dear Dr. Chin:
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 such 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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Page 2 - Dr. Robert J. Chin
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 Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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/dsma/dsmamain.html
Sincerely yours,
Muriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Rubicor Breast Biopsy Device
Indication for Use Statement
510(k) Number (if known):
Device Name:
Rubicor EnCapsule™ Breast Biopsy Device
Indications for Use:
The Rubicor EnCapsule™ Breast Biopsy Device is intended for diagnostic sampling of breast tissue during breast biopsy procedure.
The Rubicor EnCapsule™ Breast Biopsy Device is to be used for diagnostic purposes only and is not intended for therapeutic uses.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Miriam C. Provost | ||
|---|---|---|
| (Division Sign-Off) | ||
| Division of General, Restorative and Neurological Devices | ||
| 510(k) Number | K023601 | |
| Prescription Use (Per 21 CFR 801.109) | ✓ | ✓ |
| ✓ | ||
| OR | ||
| Over-the Counter Use |
Rubicor Medical, Inc.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.