(64 days)
Mammotome Biopsy Multi-Probe and Housing, Powered Suction Pump, Tubing Clamp and Tubing Accessory Arm Clamp
Not Found
No
The description focuses on the mechanical aspects of a biopsy device and does not mention any AI/ML components or functionalities.
No.
The 'Intended Use / Indications for Use' section explicitly states that the device "is for diagnostic use only and is not indicated for therapeutic use."
Yes
The "Intended Use / Indications for Use" section explicitly states, "The Mammotome® Hand-Held System is for diagnostic use only."
No
The device description clearly outlines multiple hardware components including a disposable probe, reusable holster/cable assembly, reusable control module, vacuum tubing set, canister, footswitch, support arm, and cart. This indicates it is a hardware-based medical device, not software-only.
Based on the provided information, the Mammotome® Hand-Held System 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 (like blood, urine, or tissue) to detect diseases, conditions, or infections. They are used outside of the body.
- Mammotome System Function: The description clearly states the Mammotome® Hand-Held System is a mechanical breast biopsy device. Its purpose is to obtain tissue samples from the breast within the body (incisional biopsy). It is a tool for collecting the sample, not for analyzing it.
- Intended Use: The intended use is for "incisional breast biopsy," which is a procedure to remove tissue for later diagnostic analysis. The system itself is for the collection of the sample, not the analysis of the sample.
- Diagnostic Use: While it's for "diagnostic use," this refers to the fact that the tissue sample obtained will be used for diagnosis, not that the device itself performs the diagnostic test.
The Mammotome® Hand-Held System is a medical device used in a diagnostic procedure, but it is not an in vitro diagnostic device. The diagnostic testing would be performed on the tissue sample after it is collected by the Mammotome system, likely in a laboratory using IVD methods.
N/A
Intended Use / Indications for Use
The Mammotome® Hand-Held System is indicated for use for incisional breast biopsy including microcalcifications, masses, spiculated masses, asymmetric densities, multifocal disease, and diffused tissue.
The Mammotome® Hand-Held System is for diagnostic use only and is not indicated for therapeutic use.
Product codes
KNW
Device Description
The Mammotome® Hand-Held System is a mechanical breast biopsy device used in incisional breast biopsy including microcalcifications, masses, spiculated masses, asymmetric densities, multi-focal disease, and diffused tissue.
The Mammotome® Hand-Held System consists of three major components, a disposable trocar tipped needle-like probe, a reusable holster/cable assembly, and a remote, reusable control module. The following accessories are also provided with the system: a disposable vacuum tubing set and canister, a footswitch, a support arm and a cart.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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)
Preclinical testing was performed to ensure the device performs as intended. Testing demonstrated satisfactory performance in breast tissue biopsy.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Mammotome Biopsy Multi-Probe and Housing, Powered Suction Pump, Tubing Clamp and Tubing Accessory Arm Clamp
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
991980
Section N
Mammotome® Hand-Held System 510(k) Summary of Safety and Effectiveness
Company
Ethicon Endo-Surgery, Inc. 4545 Creek Rd. Cincinnati, OH 45242
Contact
Tamima Itani, Ph.D. Director, Regulatory Affairs
Date Prepared:
June 11, 1999
Name of Device
Trade Name: Mammotome® Hand-Held System Classification Name: Biopsy Needle
Predicate Devices:
Mammotome Biopsy Multi-Probe and Housing Powered Suction Pump Tubing Clamp and Tubing Accessory Arm Clamp
Device Description
The Mammotome® Hand-Held System is a mechanical breast biopsy device used in incisional breast biopsy including microcalcifications, masses, spiculated masses, asymmetric densities, multi-focal disease, and diffused tissue.
The Mammotome® Hand-Held System consists of three major components, a disposable trocar tipped needle-like probe, a reusable holster/cable assembly, and a remote, reusable control module. The following accessories are also provided with the system: a disposable vacuum tubing set and canister, a footswitch, a support arm and a cart.
Intended Use
The Mammotome® Hand-Held System is indicated for use for incisional breast biopsy including microcalcifications, masses, spiculated masses, asymmetric densities, multifocal disease, and diffused tissue.
The Mammotome® Hand-Held System is for diagnostic use only and is not indicated for therapeutic use.
Ethicon Endo-Surgery, Inc. Mammotome Hand-Held System
06/11/99 258
1
Technological Characteristics
The Mammotome® Hand-Held System is a modification of the currently marketed Mammotome Biopsy System. While it represents a refinement over the first generation Mammotome with design, software and ergonomic enhancements for ease of use, the overall configuration, technology, materials and principles of operation of the proposed and marketed devices are equivalent.
The hand-held biopsy device, used with or without imaging modalities, provides for the diagnostic removal of tissue with fluid management through a combination of vacuum and radial cutting functions. The proposed and marketed devices contain the same primary components to achieve these functions: a probe, housing/holster, and a control module. The probe needle and cutter, which interface directly with the patient, are identical in both new and marketed devices.
In the proposed device, the housing is replaced by a holster and cable assembly and the motor resides in the control module. These physical changes make the probe lighter and more portable and facilitate user and patient interface.
The addition of a microprocessor and software allows the Mammotome® Hand-Held System to provide semi-automatic and automatic modes of operation for cutter advancement, vacuum, and specimen retrieval. Microprocessor control also provides closed-loop control to reduce dependence of cutter rotation and translation speed on user interaction or tissue variability.
In the marketed device, axial and lateral vacuum cannot be independently controlled. In the new device, axial and lateral vacuum can be controlled independently.
Performance Data
Preclinical testing was performed to ensure the device performs as intended. Testing demonstrated satisfactory performance in breast tissue biopsy.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines beneath them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 17 1999
Tamima Itani, Ph.D., RAC Director, Regulatory Affairs Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, Ohio 45242
K991980 Re:
Trade Name: Mammotome® Hand-Held System Regulatory Class: II Product Code: KNW Dated: June 11, 1999 Received: June 14, 1999
Dear Dr. Itani:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is 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 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 (Premarket Approval), 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 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 device 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.
3
Page 2 - Tamima Itani, Ph.D., RAC
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 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 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 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,
Russell U. Ayers
- 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
4
Indications for Use Statement
510(k) Number: K_991980
Device Name: Mammotome® Hand-Held System
Indication for Use:
The Mammotome® Hand-Held System is indicated for use for incisional breast biopsy including microcalcifications, masses, spiculated masses, asymmetric densities, multifocal disease, and diffused tissue.
The Mammotome® Hand-Held System is for diagnostic use only and is not indicated for 。 therapeutic use.
Russell W. Rayner Jr.
(Division Sign-Off) Division of General Restora 510(k) Number .
Prescription Use
(Per 21 CFR 801.109)