(379 days)
Not Found
No
The summary describes a mechanical biopsy device and its accessories, focusing on materials, function, and comparison to predicate devices. There is no mention of AI or ML.
No
The "Intended Use / Indications for Use" section explicitly states, "Device is for diagnostics purpose only, it is not for therapeutic use."
Yes
The "Intended Use / Indications for Use" section explicitly states "Diagnostic device used to obtain localized biopsies within breast tissue. Device is for diagnostics purpose only, it is not for therapeutic use."
No
The device description clearly details physical components made of surgical stainless steel and thermoplastics, and mentions electrosurgery capability, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for diagnostic purposes. The key is that the diagnostic process happens outside the body, on the collected specimen.
- Device Function: This device is used to obtain the biopsy specimen from within the breast tissue. It's a tool for collecting the sample, not for analyzing it in vitro.
- Intended Use: The intended use clearly states it's for "obtaining localized biopsies within breast tissue" and is for "diagnostics purpose only," but this refers to the purpose of the biopsy (to get a sample for diagnosis), not the device itself performing the in vitro diagnostic test.
- Device Description: The description focuses on the mechanical aspects of obtaining the tissue sample and its use with imaging systems and accessories. It doesn't mention any components or processes for analyzing the tissue sample itself.
This device is a biopsy device, which is a surgical instrument used to collect tissue samples. The diagnostic process would occur after the sample is obtained, likely in a laboratory using IVD methods (e.g., histology, pathology).
N/A
Intended Use / Indications for Use
Diagnostic device used to obtain localized biopsies within breast tissue. Device is for diagnostics purpose only, it is not for therapeutic use. To be used with Percutaneous Breast Biopsy Instrument Accessories (Instrument Holder, Needle Holder, and Stop), which are attached to a stereotactic table and used in conjunction with stereotactic mammographic imaging systems.
Product codes
KNW
Device Description
The PBB, a disposable breast biopsy device, is substantially equivalent to like devices in commercial distribution. These similar devices are marketed by United States Surgical Corporation (USSC), C.R. Bard, and Biopsys Medical.
PBB, USSC, C.R. Bard and Biopsys devices are all used to obtain biopsies within breast tissue. These devices are used in conjunction with instrument accessories which are used to mount the devices on a stereotactic table. These devices are all used with stereotactic mammographic imaging systems.
The PBB device is like the C.R. Bard and Biopsys devices in that they all remove a localized biopsy. These devices obturate up to the lesion, leaving intact the tissue in route to the target area.
The PBB Instrument Accessories (Instrument Holder, and Stop) are similar to the instrument holding devices marketed by USSC, Biopsys, and C.R. Bard Magnum devices in that they are all reusable devices. All of these devices are used to mount their biopsy instrument on stereotactic tables.
The PBB and similar devices on the market have components that are of similar materials that are well known and extensively used by device manufacturers. Materials which have patient contact consist of surgical stainless steel and thermoplastics. Biocompatibility testing will be conducted on sterile component samples, according to ISO-10993 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing. The testing will include, but is not limited to Cytotoxicity, Sensitization, and Irritation/Intracutaneous Reactivity. This device is categorized as Body Contact - Tissue/Bone/Dentin Communicating for a limited duration (≤ 24 hours).
The PBB device is available with and without electrosurgery capability. The PBB device with electrosurgery capability and the USSC ABBI device both have monopolar electrosurgical capability. Both are equipped with a 4mm male plug to allow their use with standard monopolar electrosurgical generators. The PBB device with Electrosurgery capability complies with the applicable safety, performance, and labeling requirements of the American National Standard Institute and Association for the Advancement of Medical Instrumentation, ANSI AAMI ES1-1993 Safe current limits for electromedical apparatus and ANSI AAMI HF18-1993 Electrosurgical devices.
The method of sterilization and the method used to validate the sterilization process are in compliance with the ANSI AAMI/ISO 11135-1994 Medical Devices - Validation and routine control of ethylene oxide sterilization.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
stereotactic mammographic imaging systems
Anatomical Site
breast tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1075 Gastroenterology-urology biopsy instrument.
(a)
Identification. A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification. (1) Class II (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
0
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g72328
Appendix II
Summary of Safety and Effectiveness
The PBB, a disposable breast biopsy device, is substantially equivalent to like devices in commercial distribution. These similar devices are marketed by United States Surgical Corporation (USSC), C.R. Bard, and Biopsys Medical.
PBB, USSC, C.R. Bard and Biopsys devices are all used to obtain biopsies within breast tissue. These devices are used in conjunction with instrument accessories which are used to mount the devices on a stereotactic table. These devices are all used with stereotactic mammographic imaging systems.
The PBB device is like the C.R. Bard and Biopsys devices in that they all remove a localized biopsy. These devices obturate up to the lesion, leaving intact the tissue in route to the target area.
The PBB Instrument Accessories (Instrument Holder, and Stop) are similar to the instrument holding devices marketed by USSC, Biopsys, and C.R. Bard Magnum devices in that they are all reusable devices. All of these devices are used to mount their biopsy instrument on stereotactic tables.
The PBB and similar devices on the market have components that are of similar materials that are well known and extensively used by device manufacturers. Materials which have patient contact consist of surgical stainless steel and thermoplastics. Biocompatibility testing will be conducted on sterile component samples, according to ISO-10993 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing. The testing will include, but is not limited to Cytotoxicity, Sensitization, and Irritation/Intracutaneous Reactivity. This device is categorized as Body Contact - Tissue/Bone/Dentin Communicating for a limited duration (≤ 24 hours).
The PBB device is available with and without electrosurgery capability. The PBB device with electrosurgery capability and the USSC ABBI device both have monopolar electrosurgical capability. Both are equipped with a 4mm male plug to allow their use with standard monopolar electrosurgical generators. The PBB device with Electrosurgery capability complies with the applicable safety, performance, and labeling requirements of the American National Standard Institute and Association for the Advancement of Medical Instrumentation, ANSVAAMI ES1-1993 Safe current limits for electromedical apparatus and ANSVAAMI HF18-1993 Electrosurgical devices.
The method of sterilization and the method used to validate the sterilization process are in compliance with the ANSVAAMI/ISO 11135-1994 Medical Devices - Validation and routine control of ethylene oxide sterilization.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, arranged in a way that they appear to be connected or overlapping.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
7 1998 JUL
Ms. Julie Powell Quality Assurance and Regulatory Affairs Director Imaging Surgical Division of Imaging Medical Technologies 8850 M89 Box 351 Richland, Michigan 49083-03513
Re: K972328
Trade Name: Percutaneous Breast Biopsy (PBB) and Percutaneous Breast Biopsy (PBB) Instrument Accessories Regulatory Class: II Product Code: KNW Dated: April 1, 1998 Received: April 2, 1998
Dear Ms. Powell:
We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market these devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your devices in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market.
2
Page 2 - Ms. Julie Powell
If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your devices, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
S. Celia M. White, Ph.D., M.D.
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known):
Percutaneous Breast Biopsy (PBB) and Percutaneous Breast Biopsy Device Name: (PBB) Instrument Accessories
Indications for Use:
Diagnostic device used to obtain localized biopsies within breast tissue. Device is for diagnostics purpose only, it is not for therapeutic use. To be used with Percutaneous Breast Biopsy Instrument Accessories (Instrument Holder, Needle Holder, and Stop), which are attached to a stereotactic table and used in conjunction with stereotactic mammographic imaging systems.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | K972328 |
| 510(k) Number |
| Prescription Use
| (Per 21 CFR 801.109) | X | OR | Over-The-Counter Use _________ |
|---|---|---|---|
| ------------------------------------------ | ------------------------------------------ | ---- | -------------------------------- |
(Optional Format 1-2-96)