(76 days)
Not Found
No
The summary describes a physical, electrosurgical localization device and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No
This device is for localization of breast lesions, not for treating them.
No
Explanation: The device is used for localization and fixation of breast lesions, not for diagnosing them. It assists in procedures like biopsies by marking the lesion, rather than making a diagnosis itself.
No
The device description explicitly states it is a "single use electrosurgical localization device," indicating it is a physical hardware device that uses electrical energy.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "localization of breast lesions." This is a procedure performed on the patient's body to mark a specific area for surgical removal or further treatment.
- Device Description: The description states it's a "single use electrosurgical localization device which is used to localize and fixate a target lesion in the breast." This confirms its use in a surgical or interventional setting, not for testing samples outside the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, tissue, urine) in vitro (outside the body) to provide information about a patient's health status, diagnose diseases, or monitor treatment. The description and intended use of the Anchor Guide™ do not involve this type of testing.
Therefore, the Anchor Guide™ Localization Device is a medical device used for a surgical or interventional procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Anchor Guide™ Localization Device is indicated for localization of breast lesions.
Product codes
KNW
Device Description
The SenoRx Anchor Guide™ Localization Device is a single use electrosurgical localization device which is used to localize and fixate a target lesion in the breast. Accessories are available separately.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
K900903, K881687/C, K790187, K963813
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
012023 1/2
SenoRx Inc. Premarket Notification Anchor Guide™ Localization Device
June 27, 2001
SEP 1 2 2001
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and CFR 807.92
1. SUBMITTER INFORMATION
| a. Company Name: | SenoRx Inc. |
|---|---|
| b. Company Address: | 11 Columbia, Suite A |
| c. Telephone: | |
| Facsimile: | (949) 362-4800 |
| (949) 362-3519 | |
| d. Contact Person: | Amy Boucly |
| Director, Regulatory Affairs | |
| and Quality Assurance |
e. Date Summary Prepared: June 27, 2001
DEVICE IDENTIFICATION 2.
Anchor Guide™ Localization Device a. Trade/Proprietary Name:
- Electrosugical cutting and coagulation b. Classification Name: device and accessories, 21 CFR 878.4400
IDENTIFICATION OF PREDICATE DEVICES 3.
| Kopans Breast Lesion
Localization Needle | Cook (K# unknown)
Milex (K900903) |
|-----------------------------------------------------|--------------------------------------------|
| Biopsy Assistant | Surgimedics (K# unknown) |
| PrecisionGuide Breast
Lesion Localization Needle | Becton-Dickinson (K881687/C) |
| Bovie Hand Control | Sybron (K790187) |
| Sure Core Biopsy
Electrode | Interventional Concepts, Inc.
(K963813) |
1
K012023 2/2
SenoRx Inc. Premarket Notification Anchor Guide™ Localization Device
June 27, 2001
DESCRIPTION OF THE DEVICE 4.
The SenoRx Anchor Guide™ Localization Device is a single use electrosurgical localization device which is used to localize and fixate a target lesion in the breast. Accessories are available separately.
STATEMENT OF INTENDED USE ડ.
The Anchor Guide™ Localization Device is indicated for localization of breast lesions.
COMPARISON WITH PREDICATE DEVICES 6.
The intended use, design, construction, materials and technology are comparable to the predicate devices.
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Public Health Service
SEP 1 2 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Amy Boucly Director, Regulatory Affairs and Quality Assurance SenoRx, Inc. 11 Columbia, Suite A Aliso Viejo, California 92656
Re: K012023
Trade/Device Name: Anchor Guide™ Localization Device Regulation Number: 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: II Product Code: KNW Dated: June 27, 2001 Received: June 28, 2001
Dear Ms. Boucly:
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 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). 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 requirements, 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 - Ms. Amy Boucly
This letter will allow you to begin marketing your device as described in your 510(k) premarket This letter will anow your of substantial equivalence of your device to a legally marketed nouticate 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 If you desire specific activer diagnostic devices), please contact the Office of Compliance at additionally 607.10 for in This craguestions on the promotion and advertising of your device, (201) 594-4639. Nathlendry, sopiance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Information on your responsional and Consumer Assistance at its toll-free number (800) 638-2041 or 1301) 443-6597 or at its internet address "http://www.fda.gov/cdrb/dsma/dsmamain.html".
Sincerely yours,
Susan Walker, MD
Image /page/3/Picture/5 description: The image contains a handwritten symbol or character. It appears to be a cursive letter, possibly a lowercase 'f' or a similar character with a loop at the top and a curved line extending to the right. The character is drawn with a thin line and has a slightly irregular shape.
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
FDA Indications for Use Page 2
510(k) number (if known): K012023
Device Name:
Anchor Guide™ Localization Device
Indications for Use: The Anchor Guide™ Localization Device is indicated for localization of breast lesions.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use
| (Per 21 CFR 801.109) | ✓ |
|---|---|
| ------------------------------------------ | --------------------------------------------------- |
| OR | |
|---|---|
| -- | ---- |
| Over-The-Counter Use | |
|---|---|
| ---------------------- | -------------------------------------------------- |
| Susan Walke | |
|---|---|
| (Division Sign-Off) | |
| Division of General, Restorative | |
| and Neurological Devices |
| 510(k) Number | K012023 |
|---|---|
| --------------- | --------------------------------------------------------- |