(27 days)
Not Found
Not Found
No
The device description focuses on a physical marker made of resorbable hydrogel and its delivery system. There is no mention of software, algorithms, image processing, AI, or ML. The intended use is purely mechanical marking for visualization.
No
The device is described as a marker for biopsy locations to aid in surgical resection, not for treating a disease or condition.
No
The device is described as a "Site Marker" that "marks the site of the biopsy tissue sample, which provides accurate visualization during surgical resection of the tumor." Its purpose is to guide surgical resection, not to diagnose a medical condition.
No
The device description explicitly states the device is made of a physical material (resorbable hydrogel) and is delivered via a physical delivery system, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "provide accuracy in marking a biopsy location for visualization during surgical resection." This describes a device used in vivo (within the body) to physically mark a site for a surgical procedure.
- Device Description: The description details a physical marker made of a resorbable hydrogel that is placed in the biopsy tract within the lung. This is a physical implant/marker, not a test performed on a sample outside the body.
- Lack of IVD Characteristics: IVD devices are typically used to examine specimens (like blood, tissue, urine) in vitro to provide information about a patient's health status, diagnose conditions, or monitor treatment. This device does none of those things. It's a physical marker for surgical guidance.
Therefore, the Biopsy Sciences, LLC., Lung Biopsy Site Marker is a surgical accessory or implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Biopsy Sciences Lung Biopsy Site Marker is intended to provide accuracy in marking a biopsy location for visualization during surgical resection.
Product codes
GDW
Device Description
Biopsy Sciences Lung Biopsy Site Markers are made of resorbable FocalSeal-L Surgical Sealant, an FDA approved hydrogel used on the surgical site during lung surgery. The FocalSeal-L hydrogel material degrades in a manner similar to absorbable sutures, via hydrolysis. The Site Markers mark the site of the biopsy tissue sample, which provides accurate visualization during surgical resection of the tumor. Lung biopsy procedures are performed by fine needle aspiration through a coaxial needle. When the fine needle aspiration device is removed, the delivery system is mated to the coaxial needle. The plunger of the delivery system is depressed, which accurately places the Site Marker in the biopsy tract.
The Biopsy Sciences Lung Biopsy Sit Markers are made of desiccated hydrogel, which immediately expands on contact with fluids to fill the biopsy tract and accurately confirm the site of biopsy during surgical resection. The markers are deployed using a hand held applicator that mates to the coaxial needle used for the biopsy procedure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lung
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Biopsy Sciences Bio-MARK Biopsy Site Marker, J&J Ethicon MicroMark, SenoRx Gel Mark Biopsy Site Marker, Artemis CoreMARK/MegaMARK Biopsy Site Identifier, Vivant Medical Biopsy Marker System, Medical Device Technologies Aspiration and Injection Needle
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
§ 878.4750 Implantable staple.
(a)
Identification. An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.
0
K 041331 P/2
May, 2004
Biopsy Sciences, LLC Traditional 510(k) Lung Biopsy Site Marker
Trade Name:
JUN 1 5 2004
4
PREMARKET NOTIFICATION [510(K)] SUMMARY
Biopsy Sciences Lung Biopsy Site Marker
| Common Name: | Biopsy site marker |
|---|---|
| Classification Name: | Instrument, biopsy (per 21 CFR section 878.4750) |
| Manufacturer's Name: | Biopsy Sciences, LLC |
| 3433 E. Fort Lowell Road | |
| Suite 103 | |
| Tucson, AZ 85716 | |
| Corresponding Official: | Sharon Rockwell |
| Vice-President RA/QA | |
| 5582 Chalon Road | |
| Yorba Linda, CA 92886 | |
| Phone: (714) 695-9269 | |
| Fax: (714) 779-0406 | |
| Predicate Biopsy Site Markers: | Biopsy Sciences Bio-MARK Biopsy Site Marker, J&J |
| Ethicon MicroMark, SenoRx Gel Mark Biopsy Site | |
| Marker, and Artemis CoreMARK/MegaMARK Biopsy | |
| Site Identifier. | |
| Predicate Localization Devices: | Vivant Medical Biopsy Marker System, and Medical |
| Device Technologies Aspiration and Injection Needle | |
| Device Description: | Biopsy Sciences Lung Biopsy Site Markers are made of |
| resorbable FocalSeal-L Surgical Sealant, an FDA | |
| approved hydrogel used on the surgical site during lung | |
| surgery. The FocalSeal-L hydrogel material degrades | |
| in a manner similar to absorbable sutures, via | |
| hydrolysis. The Site Markers mark the site of the | |
| biopsy tissue sample, which provides accurate | |
| visualization during surgical resection of the tumor. | |
| Lung biopsy procedures are performed by fine needle | |
| aspiration through a coaxial needle. When the fine | |
| needle aspiration device is removed, the delivery | |
| system is mated to the coaxial needle. The plunger of | |
| the delivery system is depressed, which accurately |
places the Site Marker in the biopsy tract.
1
K04/331 l/h
May, 2004
Biopsy Sciences, LLC Traditional 510(k) Lung Biopsy Site Marker
Intended Use:
The Biopsy Sciences Lung Biopsy Site Marker is intended to provide accuracy in marking a biopsy location for visualization during surgical resection.
Technological Characteristics:
The Biopsy Sciences Lung Biopsy Sit Markers are made of desiccated hydrogel, which immediately expands on contact with fluids to fill the biopsy tract and accurately confirm the site of biopsy during surgical resection. The markers are deployed using a hand held applicator that mates to the coaxial needle used for the biopsy procedure.
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 seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 5 2004
Biopsy Sciences, LLC c/o Ms. Sharon Rockwell Vice President RA/QA 5582 Chalon Road Yorba Linda, California 92886
Re: K041331
Trade/Device Name: Lung Biopsy Site Marker Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable Staple Regulatory Class: II Product Code: GDW Dated: May 10, 2004 Received: May 19, 2004
Dear Ms. Rockwell:
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 or any I 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 Erth 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 - Ms. Sharon Rockwell
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin mails and of substantial equivalence of your device to a legally prematics notification: "The 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 If you desire specific acriously 31 (301) 594-4659. Also, please note the regulation entitled, Colliation of Orition of Compulation in (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small biller general informational 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
K04/331
Indications for Use
510(k) Number (if known): K041331
Device Name: Lung Biopsy Site Marker
Indications For Use: The Biopsy Sciences, LLC., Lung Biopsy Site Marker is intended to provide accuracy in marking a biopsy location for visualization during surgical resection.
Prescription Use _X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
iriam C. Provost
Division of General, Restorative, and Neurological Devices
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
510(k) Number K64/33/