(49 days)
None
No
The description focuses on the material composition and mechanical delivery system of a physical tissue marker. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
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 for future surgical procedures or during a surgical procedure, not 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 needle, shaft, handle, push rod, plunger, and end cap. These are hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "radiographically mark soft tissue during a surgical procedure or for future surgical procedures." This is a physical marking of tissue within the body for imaging purposes.
- Device Description: The device is a physical marker made of PEKK and Barium Sulfate, delivered via a needle system. It is placed into the tissue.
- Lack of In Vitro Activity: IVD devices are used to examine specimens outside of the body (in vitro) to provide information about a patient's health. This device does not analyze or test any biological samples. It is a physical marker placed within the body.
The device is clearly intended for use in vivo (within the living body) to aid in medical imaging and surgical procedures, not for diagnostic testing of samples in a lab setting.
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.
The proposed Beacon Tissue Marker delivery system is a distal delivery needle tip, rigid shaft, sterile, and single patient use preloaded delivery system incorporating the Beacon Tissue Marker. The delivery system consists of a cannula with a handle, a push rod with a plunger, and an end cap. 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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
K130763 page 1/2
MAY 0 8 2013
",
| 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: | Joseph Ostendorf | ||
| Regulatory Affairs Consultant | |||
| Scion Medical Technologies |
Address: 23879 Blue Spruce Road
Sauk Centre, MN 56378
U.S.A.
Telephone: (503) 784-6756
Fax: (888) 582 - 6211
E-mail: jeostendorf@gmail.com | | |
| Date Prepared: | 7 May 2013 | | |
| 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
Devices: | KMD-Mark1 Tissue
Marker | K093473 | July 02, 2010 |
| | BiomarC® Tissue
Marker | K063193 | November 21, 2006 |
| 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 | | |
()
()
()
510(k) Summary
1
Sulfate (Polyetherketoneketone with 20% BaSO4 by wt%). OXPEKK-IG200 is a radiolucent material and serves as the carrier for the radiopaque BaSO4.
The proposed Beacon Tissue Marker delivery system is a distal delivery needle tip, rigid shaft, sterile, and single patient use preloaded delivery system incorporating the Beacon Tissue Marker. The delivery system consists of a cannula with a handle, a push rod with a plunger, and an end cap. 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.
The Beacon Tissue Marker is indicated for use to radiographically
mark soft tissue during a surgical procedure or for future surgical
Indications for Use:
procedures.
Technological Characteristics:
Conclusion:
The purpose of this premarket notification is to seek clearance for a device modification to the Kent Medical Devices, Inc. KMD-Mark1 Tissue Marker (K093473, cleared on July 02, 2010), specifically for the modification of the already cleared and unchanged KMD-Mark1 soft tissue marker (K093473, cleared on July 02, 2010) to be inserted into the already cleared and currently marketed BiomarC tissue marker delivery system (K063193, cleared on November 21, 2006). The modified device will be marketed by Scion Medical Technologies, LLC under the trade name Beacon Tissue Marker.
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 Kent Medical Devices, Inc. KMD-Mark1 Tissue Marker (K093473), which was determined to be substantially equivalent and cleared on July 02, 2010, and the predicate Carbon Medical Technologies, Inc. BiomarC Tissue Marker (K063193), which was determined to be substantially equivalent and cleared on November 21, 2006.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of a human figure embracing a bird, which is meant to represent the department's mission of protecting the health of all Americans and providing essential human services. The logo is in black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Scion Medical Technologies LLC % Ostendorf Consulting Mr. Joseph Ostendorf 23879 Blue Spruce Road Sauk Centre, Minnesota 56378
May 8, 2013
Re: K130763
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 03, 2013 Received: April 08, 2013
Dear Mr. Ostendorf:
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
3
Page 2 - Mr. Joseph Ostendorf
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-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 Small Manufacturers, International and Consumer Assistance at its tollfree 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/Safetv/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industrv/default.htm.
Sincerely yours, FOR
Peter D. Rumm -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Beacon Tissue Marker
Indications for Use
510(k) Number (if known): K130763
Device Name:
Beacon Tissue Marker™
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.
Prescription Use _ x (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use_ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) David Krause S
(Division Sign-Off) Division of Surgical Devices 510(k) Number: K130763
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