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.

AI/ML Overview

The provided document is a 510(k) summary for the Beacon Tissue Marker, which describes a device modification. It states that the purpose of the submission is to seek clearance for a modification to an already cleared tissue marker to be inserted into an already cleared delivery system.

Therefore, this document does not describe a study that proves the device meets acceptance criteria. Instead, it focuses on demonstrating substantial equivalence to pre-existing predicate devices based on the modification of components already cleared by the FDA. The submission largely relies on the prior clearance of its constituent parts and asserts that the combined device does not raise new questions of safety or efficacy.

As a result, I cannot provide the specific details requested in your prompt regarding acceptance criteria, reported device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone performance. These types of studies would typically be conducted for novel devices or significant modifications, which is not the case described here.

The document indicates that the change is the combination of:

KMD-Mark1 Tissue Marker (K093473) - already cleared
BiomarC® Tissue Marker delivery system (K063193) - already cleared

The document states: "Scion Medical Technologies, LLC believes that the proposed Beacon Tissue Marker... 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)... and the predicate Carbon Medical Technologies, Inc. BiomarC Tissue Marker (K063193)."

This type of submission often relies on a comparison of technical characteristics and existing performance data of the predicate devices rather than new, extensive clinical studies for the combined product.

Summary

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K130763 page 1/2

MAY 0 8 2013

510(k) Summary
Submitter'sName andAddress:	Scion Medical Technologies, LLC90 Oak StreetNewton, MA 02464U.S.A.
Contact Nameand Information:	Joseph OstendorfRegulatory Affairs ConsultantScion Medical TechnologiesAddress: 23879 Blue Spruce RoadSauk Centre, MN 56378U.S.A.Telephone: (503) 784-6756Fax: (888) 582 - 6211E-mail: jeostendorf@gmail.com
Date Prepared:	7 May 2013
ProprietaryName(s):	Beacon Tissue Marker™
Common Name:	Implantable Clip
ClassificationPanel	General and Plastic Surgery
Classification ofDevice:	Class II, 21 CFR 878.4300
Product Code:	NEU
PredicateDevices:	KMD-Mark1 TissueMarker	K093473	July 02, 2010
	BiomarC® TissueMarker	K063193	November 21, 2006
DeviceDescription:	The proposed Beacon Tissue Marker consists of a radiographicsoft tissue marker and the delivery system. The proposed BeaconTissue Marker is a sterile, single patient use, PEKK discretemarker that is visible on standard radiographs (x-ray,mammography) as well as ultrasound, and Magnetic ResonanceImaging (MRI) at up to 3.0 Tesla field strength. The proposedBeacon Tissue Marker is placed into soft tissue during open,percutaneous, or endoscopic procedures to radiographically marka surgical location.The proposed Beacon Tissue Marker is comprised of OxfordPerformance Materials (OPM) OXPEKK-IG200 filled with Barium

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510(k) Summary

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Sulfate (Polyetherketoneketone with 20% BaSO4 by wt%). OXPEKK-IG200 is a radiolucent material and serves as the carrier for the radiopaque BaSO4.

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.

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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

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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

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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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Scion Medical Technologies, LLC

Regulation Number and Section

§ 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.