(48 days)
No
The device description focuses on the physical components and materials of a tissue marker and its delivery system. There is no mention of software, algorithms, or any capabilities that would suggest the use of AI or ML for image analysis, diagnosis, or any other function.
No
The device is used to radiographically mark soft tissue for future surgical procedures, not to treat a disease or condition.
No
The device is a tissue marker used to radiographically mark soft tissue; it does not collect, analyze, or interpret data to diagnose a condition.
No
The device description clearly outlines physical components: a radiographic soft tissue marker made of PEKK and Barium Sulfate, and a delivery system consisting of a cannula, handle, push rod, plunger, tabs, and tip cover. These are hardware components, not software.
No, 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 (like blood, urine, or tissue) to provide information about a person's health. They are used outside of the body (in vitro).
- Beacon Tissue Marker Function: The Beacon Tissue Marker is a physical object placed inside the body (in vivo) to mark a location for imaging or future surgical procedures. It does not analyze biological samples or provide diagnostic information based on those samples. Its purpose is purely for anatomical localization and visualization on imaging modalities.
The description clearly states its function is to "radiographically mark soft tissue during a surgical procedure or for future surgical procedures," and it is "placed into soft tissue." This is a direct intervention within the body, not an in vitro test.
N/A
Intended Use / Indications for Use
The Beacon Tissue Marker is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures.
Product codes
NEU
Device Description
The proposed Beacon Tissue Marker consists of a radiographic soft tissue marker and the delivery system. The proposed Beacon Tissue Marker is 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. The proposed Beacon Tissue Marker is placed into soft tissue during open, percutaneous, or endoscopic procedures to radiographically mark a surgical location.
The proposed Beacon Tissue Marker is comprised of Oxford Performance Materials (OPM) OXPEKK-IG200 filled with Barium Sulfate (Polyetherketoneketone with 20% BaSO4 by wt%). OXPEKK-IG200 is a radiolucent material and serves as the carrier for the radiopaque BaSO4.
single patient use, pre-loaded delivery system incorporating the Beacon Tissue Marker. The delivery system consists of a cannula with a handle, a push rod with a plunger, tabs to retain the tissue marker, 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. The Beacon Tissue Marker delivery system is used to place the Beacon Tissue Marker into soft tissue during open, percutaneous, or endoscopic procedures to radiographically mark a surgical location. The delivery system device has a beveled 12 cm / 14 gauge needle with 1 cm depth marks and a plunger.
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)
Substantial equivalence of the proposed device was determined through functional, deployment, and package integrity testing. Specifically, testing included deployment force, marker expulsion, component bond strength, marker retention, dimensional, pouch peel, and pouch leak. All testing met pre-defined acceptance criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Beacon Tissue Marker K130763, KMD-Mark1 Tissue Marker (K093473), BiomarC Tissue Marker (K063193)
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
and the comments of the comments of the comments of the comments of the comments of
| 510(k) Summary | |
|---|---|
| Submitter's | |
| Name and | |
| Address: | Scion Medical Technologies, LLC |
| 90 Oak Street | |
| Newton, MA 02464 | |
| U.S.A. | |
| Contact Name | |
| and Information: | Chris Lewis |
| Director QA/RA | |
| Scion Medical Technologies, LLC |
Address: Scion Medical Technologies, LLC
90 Oak Street
Newton, MA 02464
U.S.A.
Telephone: (617) 209-5629
Fax: (888) 963-9112
E-mail: chris@scionmedtech.com |
| Date Prepared: | 28 March 2014 |
| Proprietary
Name(s): | Beacon Tissue Marker™ |
| Common Name: | Implantable Clip |
| Classification
Panel | General and Plastic Surgery |
| Classification of
Device: | Class II, 21 CFR 878.4300 |
| Product Code: | NEU |
| Predicate
Device: | Beacon Tissue Marker K130763 May 8th, 2013 |
| Device
Description: | The proposed Beacon Tissue Marker consists of a radiographic
soft tissue marker and the delivery system. The proposed
Beacon Tissue Marker is 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. The proposed
Beacon Tissue Marker is placed into soft tissue during open,
percutaneous, or endoscopic procedures to radiographically mark
a surgical location.
The proposed Beacon Tissue Marker is comprised of Oxford
Performance Materials (OPM) OXPEKK-IG200 filled with Barium
Sulfate (Polyetherketoneketone with 20% BaSO4 by wt%).
OXPEKK-IG200 is a radiolucent material and serves as the carrier
for the radiopaque BaSO4. |
| | single patient use, pre-loaded delivery system incorporating the
Beacon Tissue Marker. The delivery system consists of a
cannula with a handle, a push rod with a plunger, tabs to retain
the tissue marker, 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. The Beacon Tissue Marker delivery system is used to
place the Beacon Tissue Marker into soft tissue during open,
percutaneous, or endoscopic procedures to radiographically mark
a surgical location. The delivery system device has a beveled
12 cm / 14 gauge needle with 1 cm depth marks and a plunger. |
| Indications for
Use: | The Beacon Tissue Marker is indicated for use to radiographically
mark soft tissue during a surgical procedure or for future surgical
procedures. |
| Technological
Characteristics: | The designs of the predicate and proposed Beacon Tissue
Markers are the same. Both devices use the same PEKK tissue
marker, with the same geometry, and a 20% BaSO4 loading. The
delivery systems are also functionally equivalent. The materials
are the same and the plunger/cannula deployment mechanisms
are the same. Overall length and system features are equivalent.
Both devices employ a retention mechanism to retain the marker
in the delivery system. The predicate delivery system uses a
vestamid sleeve retention mechanism that is bonded to the ID of
the cannula. The proposed device uses two tabs that are
precision laser cut into the distal tip of the stainless steel cannula
that are bent inward to create a narrowed section in the cannula
body to retain the marker. |
| Non-Clinical
Testing: | Substantial equivalence of the proposed device was determined
through functional, deployment, and package integrity testing.
Specifically, testing included deployment force, marker expulsion,
component bond strength, marker retention, dimensional, pouch
peel, and pouch leak. All testing met pre-defined acceptance
criteria. |
| Conclusion: | In summary, Scion Medical Technologies, LLC believes that the
proposed Beacon Tissue Marker, as described in this submission,
does 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 (K130763)
cleared on May 8th, 2013 which is comprised of the Kent Medical
Devices, Inc. KMD-Mark1 Tissue Marker (K093473), which was
determined to be substantially equivalent and cleared on July 02,
2010, and the Carbon Medical Technologies, Inc. BiomarC Tissue
Marker (K063193), which was determined to be substantially
equivalent and cleared on November 21, 2006. |
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three tail feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 20, 2014
Scion Medical Technologies Incorporated Mr. Chris Lewis Director, Quality Assurance/Regulatory Affairs 90 Oak Street Newton, Massachusetts 02464
Re: K140835
Trade/Device Name: Beacon Tissue Marker" Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: Class II Product Code: NEU Dated: April 23, 2014 Received: April 25, 2014
Dear Mr. Lewis:
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 or any routh 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-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Mr. Chris Lewis
: -
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" (21CFR 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 yours,
David Krause -S
for
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No, 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
510(k) Number (if known) K140835
Device Name Beacon Tissue Marker™
Indications for Use (Describe)
The Beacon Tissue Marker is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures.
Type of Use (Select one or both, as applicable)
7 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
FORM FDA 3881 (9/13)
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