(281 days)
No
The summary describes a physical tissue marker and delivery system, with no mention of software, algorithms, or any technology related to AI or ML.
No.
The device is used to mark a biopsy location, which is a diagnostic aid rather than a therapeutic intervention.
No
The device is used to mark the location of a biopsy procedure for future radiographic and radiological identification, not to diagnose a condition.
No
The device description explicitly states it consists of a delivery device (applier), introducer cannula, and non-absorbable tissue marker, which are all hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to physically mark a biopsy site within the body for future imaging. This is a physical intervention and marking, not a test performed in vitro (outside the body) on biological samples to diagnose a condition.
- Device Description: The device consists of an applier, cannula, and tissue marker. These are tools for a physical procedure, not components of a diagnostic test kit.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), reagents, or any process that would be characteristic of an in vitro diagnostic test.
The device is a medical device used in vivo (within the body) to facilitate future diagnostic imaging.
N/A
Intended Use / Indications for Use
The Sanarus Indica Marker System is indicated for use to attach to soft tissue, including breast tissue, following an open surgical or percutaneous biopsy procedure and to radiographically and radiologically mark the location of the biopsy procedure.
Product codes
GDW, FZP
Device Description
The Sanarus Indica Marker System consists of a delivery device (applier), introducer cannula and non-absorbable tissue marker that is clearly visible on standard radiographs and ultrasound.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Radiographs, Ultrasound
Anatomical Site
Soft tissue, including breast tissue
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)
Biocompatibility and bench testing have demonstrated that the device is safe and effective and that its performance is equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4300 Implantable clip.
(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.
0
KOZOO 54
OCT 1 6 2002
Section II - Summary of Safety and Effectiveness
(1) Contact Information
Vincent Cutarelli Vice President, Regulatory Affairs Telephone: (949) 768-1184 ext. 105
Company Information (2)
Sanarus Medical, Inc. 5880 W. Las Positas Blvd., Suite 52 Pleasanton, CA 94588 Telephone: (925) 460-6080 FAX: (925) 460-6084
(3) Device Name
Sanarus Indica Marker System
Device Description (4)
The Sanarus Indica Marker System consists of a delivery device (applier), introducer cannula and non-absorbable tissue marker that is clearly visible on standard radiographs and ultrasound.
(5) Indications for Use
The Sanarus Indica Marker System is indicated for use to attach to soft tissue, including breast tissue, following an open surgical or percutaneous biopsy procedure and to radiographically and radiologically mark the location of the biopsy procedure.
Name of Predicate or Legally Marketed Device (6)
Senorx, Inc. Gel Mark Biopsy Site Marker (reference K000060) Advanced UroScience, Inc. Tissue Marker (reference K001807) Inrad, Inc. UltraClip Tissue Marker (reference K993785)
1
Technological Characteristics and Performance Summary (7)
The design, construction and materials are similar to or equivalent to the marketed predicate devices. Biocompatibility and bench testing have demonstrated that the device is safe and effective and that its performance is equivalent to the predicate devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
1 6 2002
Sanarus Medical, Inc. Vincent Cutarelli Vice President, Regulatory Affairs 5880 West Las Positas, Suite 52 Pleasanton, California 94588
Re: K020054
Trade/Device Name: Sanarus Indica Marker System Regulation Number: 878.4750; 878.4300 Regulation Name: Implantable staple; Implantable clip Regulatory Class: Class II Product Code: GDW; FZP Dated: July 17, 2002 Received: July 18, 2002
Dear Mr. Cutarelli:
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.
3
Page 2 – Mr. Vincent Cutarelli
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 vour 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 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,
Muriam C. Provost
for 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
·
102005 510(k) Number: _
Device Name:
Indications for Use: The Sanarus Indica Marker System is indicated for use to attach to soft tissue, including breast tissue, following an open surgical or percutaneous biopsy ... procedure and to radiographically and radiologically mark the location of the biopsy procedure.
Concurrence of CDRH, Office of Device Evaluation (ODE):
Miriam C. Provost
Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number
Prescription Use: _ X (Per 21 CFR 801.109)