(14 days)
Not Found
No
The summary describes a mechanical biopsy device and does not mention any AI or ML components or functions.
No
The "Intended Use / Indications for Use" section explicitly states that the instruments "are to be used for diagnostic purposes only and are not intended for therapeutic use."
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states, "The instruments are to be used for diagnostic purposes only".
No
The device description clearly outlines physical components like a Motorized Cutter, Introducer, handle, aspiration port, and trocar, indicating it is a hardware device.
Based on the provided information, the Acueity Excisor Bioptome is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to examine these samples outside of the body.
- Device Function: The Acueity Excisor Bioptome is a device used to obtain a soft tissue breast biopsy. It is a mechanical coring device that physically removes tissue from the body.
- Intended Use: The intended use is for "obtaining a soft tissue breast biopsy" and for "diagnostic purposes only." While the tissue sample obtained by this device will likely be used for in vitro diagnostic testing (e.g., pathology examination), the device itself is the tool for collecting the sample, not for performing the diagnostic test on the sample.
Therefore, the Acueity Excisor Bioptome is a device used in the process of diagnosis, but it is not an in vitro diagnostic device itself. It's a biopsy device used to acquire the specimen that will then be analyzed using IVD methods.
N/A
Intended Use / Indications for Use
The Acueity Excisor Bioptome is a multiple action biopsy system intended for obtaining a soft tissue breast biopsy. The instruments are to be used for diagnostic purposes only and are not intended for therapeutic use.
Product codes (comma separated list FDA assigned to the subject device)
KNW
Device Description
The Excisor Bioptome is a percutaneous, mechanical coring device utilizing imaging quidance such as ultrasound and X-ray for breast biopsy. The basic structure of the device includes a Motorized Cutter and detachable stainless steel Introducer with aluminum handle or finger piece and aspiration port and a stainless steel trocar.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound and X-ray
Anatomical Site
breast
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
All necessary testing will be performed on the Exisor Bioptome to ensure that the product is substantially equivalent to the predicate devices and to ensure that the new device does not have a significant effect on safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
US Biopsy Single Action Bioipsy Device (K954231), Ethicon Mammotome Hand Held System (K991980)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
K03284-7
510(k) Notification Excisor Bioptome
510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
Name. Address, Phone and Fax number of the Applicant A.
Acueity, Inc. 100 Hamilton Avenue, Suite 140 Palo Alto, CA 94301
(650) 473-9910 Telephone: Fax: (650) 473-9306
Contact Person B.
Nancy Lincé Regulatory Affairs Consultant
Telephone: (650) 759-6186
C. Date Prepared
August 12, 2003
D. Device Name
Trade Name: Excisor Bioptome Classification Name: Instrument, Biopsy
E. Device Description
The Excisor Bioptome is a percutaneous, mechanical coring device utilizing imaging quidance such as ultrasound and X-ray for breast biopsy. The basic structure of the device includes a Motorized Cutter and detachable stainless steel Introducer with aluminum handle or finger piece and aspiration port and a stainless steel trocar.
1
Intended Use F.
The Acueity Excisor Bioptome is a multiple action biopsy system intended for obtaining a soft tissue breast biopsy. The instruments are to be used for diagnostic purposes only and are not intended for therapeutic use.
G. Substantial Equivalence
The Excisor Bioptome is substantially equivalent to the US Biopsy Single Action Bioipsy Device (K954231) and the Ethicon Mammotome Hand Held System (K991980). It has the same intended use, materials and principles of operation as the predicate devices. All three devices are designed to perform percutaneous breast biopsy using a tubular cannula with trocar/needle to penetrate the tissue and access the biopsy site.
H. Device Testing Results and Conclusion
All necessary testing will be performed on the Exisor Bioptome to ensure that the product is substantially equivalent to the predicate devices and to ensure that the new device does not have a significant effect on safety and effectiveness.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is enclosed within a circular border, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the border. The text is in all caps and is evenly spaced around the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 6 2003
Acueity, Inc. c/o Mr. Peter N. Ruvs N.V. KEMA P.O. 9035 6800 Et Arnhem Arnhem, Netherlands
Re: K032847
Trade/Device Name: Excisor Bioptome Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: II Product Code: KNW Dated: September 11. 2003 Received: September 12, 2003
Dear Mr. Ruys:
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. Iisting 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.
3
Page 2 - Mr. Peter N. Ruys
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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Miriam 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
4
Acueity, Inc.
510(k) Number (if known): K__________________________________________________________________________________________________________________________________________________
Device Name: Excisor Bioptome
Indications For Use:
The Acueity Excisor Bioptome is a multiple action biopsy system intended for obtaining a soft tissue breast biopsy. The instruments are to be used for diagnostic purposes only and are not intended for therapeutic use.
Miriame. Provost
Division of General, Restorative and Neurological Devices
510(k) Number K032847
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_
OR (Per 21 CFR 801.109) Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)