(30 days)
Not Found
No
The device description focuses solely on the physical components and delivery mechanism of a tissue marker, with no mention of any software, algorithms, or data processing capabilities that would indicate the use of AI or ML. The "Mentions AI, DNN, or ML" and "Description of the training set..." sections are explicitly marked as "Not Found".
No
The device is described as a tissue marker used for radiographic marking of soft tissue, not for treating a disease or condition.
No
This device is a tissue marker used to radiographically mark soft tissue for surgical procedures. It is not used to diagnose a condition or disease.
No
The device description explicitly details physical components including a radiographic soft tissue marker made of PEKK, a delivery system with a needle, handle, push rod, plunger, and tip cover. This indicates 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:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. These tests are performed outside of the body (in vitro).
- Device Function: The Star Tissue Marker is a device that is implanted into soft tissue within the body to provide a radiographic marker. It is used in vivo (within the living organism) to mark a location for future imaging or surgical procedures.
- Lack of In Vitro Testing: The description does not mention any testing performed on samples taken from the body. The device's function is to be a physical marker within the body.
Therefore, the Star Tissue Marker falls under the category of an implantable medical device rather than an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Star Tissue Marker is indicated for use to radiographically mark soft tissue at the surgical procedure or for future surgical procedures
Product codes
NEU
Device Description
The Star Tissue Marker consists of a radiographic soft tissue marker and the delivery system. The Star Tissue Marker includes a sterile, single patient use, PEKK discrete marker that is visible on standard radiographs (x-ray, mammography) as well as ultrasound, and Magnetic Resonance Imaging (MRI) at up to 3.0 Tesla field strength.
This submission is for a new cross sectional profile of the tissue marker. The delivery system is sterile, single patient use, and is pre-loaded incorporating the tissue marker. The delivery system has a 12 cm /14 gauge needle with 1 cm depth marks. The delivery system consists of a cannula with a handle with integral tabs to retain the tissue marker, a push rod with a plunger, and a tip cover. The tissue marker is retained within the delivery system until placement is desired, where it is delivered through the end port by fully depressing the plunger into the handle.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
standard radiographs (x-ray, mammography) as well as ultrasound, and Magnetic Resonance Imaging (MRI)
Anatomical Site
soft 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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
Image /page/0/Picture/2 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 a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 27, 2017
Scion Medical Technologies, LLC Mr. Louis Li Director of OA/RA 4613 West Chester Pike Newtown Square, Pennsylvania 19073
Re: K170905
Trade/Device Name: Star Tissue Marker Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: Class II Product Code: NEU Dated: February 28, 2017 Received: March 28, 2017
Dear Mr. Li:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device
1
related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
David Krause -S
for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K170905
Device Name
Star Tissue Marker
Indications for Use (Describe)
Star Tissue Marker is indicated for use to radiographically mark soft tissue at the surgical procedure or for future surgical procedures
| Type of Use (Select one or both , as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) |
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Special 510(k) Summarv as required by 21 CFR 807.92(a)
| A) Submitted by: | Scion Medical Technologies, LLC | |
|---|---|---|
| 4613 West Chester Pike | ||
| Newtown Square, Pennsylvania 19073 | ||
| USA | ||
| TEL: (484)860-2685 | ||
| Official Contact: | Louis Li Director of QA/RA | |
| B) Common name: | Implantable Clip | |
| Proprietary Name: | Star Tissue Marker | |
| Device Class: | Class II, 21 CFR 878.4300 | |
| Regulation and | ||
| Classification name: | marker, radiographic, implantable | |
| Product code: | NEU | |
| Classification panel: General and Plastic Surgery | ||
| C) Predicate: | Beacon Tissue Marker K140835 May 20th, 2014 |
D) Date Prepared: April 26, 2017
E) Device Description
The Star Tissue Marker consists of a radiographic soft tissue marker and the delivery system. The Star Tissue Marker includes a sterile, single patient use, PEKK discrete marker that is visible on standard radiographs (x-ray, mammography) as well as ultrasound, and Magnetic Resonance Imaging (MRI) at up to 3.0 Tesla field strength.
This submission is for a new cross sectional profile of the tissue marker. The delivery system is sterile, single patient use, and is pre-loaded incorporating the tissue marker. The delivery system has a 12 cm /14 gauge needle with 1 cm depth marks. The delivery system consists of a cannula with a handle with integral tabs to retain the tissue marker, a push rod with a plunger, and a tip cover. The tissue marker is retained within the delivery system until placement is desired, where it is delivered through the end port by fully depressing the plunger into the handle.
F) Intended Use/Indications For Use:
The Star Tissue Marker is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures
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- G) Substantial Equivalence Comparison and Discussion
In summary, Scion Medical Technologies, LLC believes that the proposed changes in Star Tissue Marker, as described in this submission, do not raise any new or significant questions of safety and efficacy and is substantially equivalent to the predicate Scion Medical Technologies, LLC Beacon Tissue Marker cleared on May 20th, 2014 (K140835).
H) Compliance with Design Controls
The results of assessment of the change to the new tissue marker conducted under Design Controls, support that the new offering is substantially equivalent to the predicate tissue marker.
Compliance with Standards:
ISO 15223-1:2012, Medical devices - Symbols to be used with medical device labels, labeling and information to be supplied - Part 1: General requirements
ISO 14971: 2007, Medical devices - Application of risk management to medical devices
EN 1041:2008 Information supplied by the manufacture of medical devices