(88 days)
Not Found
No
The summary describes a physical localization device and its delivery system, with no mention of software, image processing, AI, or ML. The performance study focuses on the mechanical deployment of the device.
No
The device is intended for localization of non-palpable breast lesions to facilitate surgical excision, which is a diagnostic or preoperative planning function, not a therapeutic one.
No
The device is used for localization to facilitate surgical excision, not for diagnosing the presence or nature of a condition.
No
The device description explicitly states it is a "disposable instrument consisting of a curved localization element and a needle cannula delivery system," which are physical hardware components.
No, this device 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 provide information for diagnosis, monitoring, or screening.
- Device Function: The enCircle™ Localization Device is a surgical instrument used to physically mark the location of a lesion within the breast tissue before surgery. It is used in vivo (within the living body) to guide the surgeon during the excision procedure.
- Lack of Diagnostic Testing: The device itself does not perform any diagnostic tests on biological samples. It does not analyze tissue or fluids to determine the nature of the lesion.
Therefore, based on its intended use and function, the enCircle™ Localization Device falls under the category of a surgical instrument or device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The enCircle™ Localization Device is intended for localization of non-palpable breast lesions.
Product codes
KNW
Device Description
The enCircle™ Localization Device is a disposable instrument consisting of a curved localization element and a needle cannula delivery system. The device is used to localize non-palpable breast lesions to facilitate surgical excision of the lesions.
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
In-Vitro testing, comparing the performance of the enCircle™ Localization Device versus the previously cleared Vivant Breast Lesion Localization Device, revealed equivalent performance with improved consistency of deployment.
Key Metrics
Not Found
Predicate Device(s)
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.
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510(k) Summary
General Information
| Classification | Class II |
|---|---|
| Trade Name | enCircle™ Localization Device |
| Submitter | Vivant Medical, Inc. |
| 1916-A Old Middlefield Way | |
| Mountain View, CA 94043 | |
| 650-694-2900 | |
| Contact | Steven Kim |
| Director, Research & Development |
Intended Use
The enCircle™ Localization Device is intended for localization of non-palpable breast lesions.
Predicate Devices
| Breast Lesion Localization Device - Vivant Medical, Inc. | K003439 |
|---|---|
| Bovie Hand Control - Sybron Corporation | K790187 |
Device Description
The enCircle™ Localization Device is a disposable instrument consisting of a curved localization element and a needle cannula delivery system. The device is used to localize non-palpable breast lesions to facilitate surgical excision of the lesions.
Materials
All materials used in the manufacture of the enCircle™ Localization Device are suitable for this use and have been used in numerous previously cleared products.
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Kozzz86
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Testing
In-Vitro testing, comparing the performance of the enCircle™ Localization Device versus the previously cleared Vivant Breast Lesion Localization Device, revealed equivalent performance with improved consistency of deployment.
Summary of Substantial Equivalence
The enCircle™ Localization Device is equivalent to the original device from Vivant Medical as well as the RF Electrosurgical predicate product. The indications for use, basic overall function, methods of manufacturing, and materials used are substantially equivalent. Vivant Medical believes the enCircle™ Localization Device is substantially equivalent to existing legally marketed devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Public Health Service
OCT 11 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Steven Kim Director, Research and Development Vivant Medical, Inc. 1916-A Old Middlefield Way Mountain View, CA 94043
Re: K022286
Trade/Device Name: enCircle™ Localization Device Regulation Number: 878.4800 Regulation Name: Manual surgical instrument for general use Regulatory Class: II Product Code: KNW Dated: July 12, 2002 Received: July 15, 2002
Dear Mr. Kim:
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 – Mr. Steven Kim
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" (21CFR 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,
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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Indications for Use
. . . . . . . . . . . .
.
:
| 510(k) Number (if known): | This application |
|---|---|
| Device Name: | enCircle™ Localization Device |
| Indications for Use: | The enCircle™ Localization Device is |
| intended for localization of non-palpable | |
| 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
(Optional Format 1-2-96) |
| ------------------------------------------ | ---- | -------------------------------------------------- |
|---|
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
| 510(k) Number | K022286 |
|---|---|
| --------------- | --------- |