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 delivery system is a sterile, 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.

AI/ML Overview

Here's an analysis of the acceptance criteria and study for the Beacon Tissue Marker, based on the provided 510(k) summary:

Device: Beacon Tissue Marker™ (Implantable Clip)

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion	Device Performance (as stated in 510(k) Summary)
Functional Testing (e.g., deployment force, marker expulsion, marker retention)	All testing met pre-defined acceptance criteria.
Deployment Testing	All testing met pre-defined acceptance criteria.
Component Bond Strength Testing	All testing met pre-defined acceptance criteria.
Dimensional Testing	All testing met pre-defined acceptance criteria.
Package Integrity Testing (e.g., pouch peel, pouch leak)	All testing met pre-defined acceptance criteria.

2. Sample Size Used for the Test Set and Data Provenance

The 510(k) summary does not specify the exact sample sizes used for each of the non-clinical tests (e.g., deployment force, marker expulsion, etc.). It only broadly states that "All testing met pre-defined acceptance criteria."

The data provenance is also not explicitly stated in terms of country of origin or whether the studies were retrospective or prospective. Given that this is a non-clinical, bench-top testing summary, it would typically be prospective testing conducted in a laboratory setting.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable and not provided in the 510(k) summary. The testing described for this device is non-clinical, engineering-based performance testing (e.g., deployment force, bond strength, dimensions). There is no mention of medical image interpretation or human subject studies that would require experts to establish a "ground truth" for diagnostic or clinical performance.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving human interpretation or subjective assessments, which are not described in the non-clinical testing for this device.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done, nor is it relevant for the type of device and testing described. MRMC studies are used to assess the impact of a medical device (often AI-assisted diagnostic tools) on human reader performance in interpreting medical images or data. The Beacon Tissue Marker is an implantable clip for marking soft tissue, and its performance is evaluated through engineering and biocompatibility testing, not clinical diagnosis or interpretation by human readers.

6. Standalone (Algorithm Only Without Human-in-the-loop Performance) Study

No. A standalone algorithm performance study was not done. This device is a physical implantable marker and does not involve any algorithms or artificial intelligence for its function or evaluation in the context of this 510(k) summary.

7. Type of Ground Truth Used

The "ground truth" for the non-clinical testing consisted of engineering specifications and predefined performance thresholds. For example:

Deployment force might have a specified range (e.g., 5N-15N).
Marker retention might be evaluated by ensuring the marker does not prematurely release under specified forces.
Dimensions would be compared against design specifications.
Package integrity would be assessed against industry standards for sterility barrier and leak protection.

There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for this type of non-clinical device testing.

8. Sample Size for the Training Set

This information is not applicable and not provided. Since the device does not involve algorithms or AI, there is no "training set" in the context of machine learning. The testing performed is to validate the physical and functional aspects of the device against engineering requirements.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable (as there is no training set).

Summary

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and the comments of the comments of the comments of the comments of the comments of

	510(k) Summary
Submitter'sName andAddress:	Scion Medical Technologies, LLC90 Oak StreetNewton, MA 02464U.S.A.
Contact Nameand Information:	Chris LewisDirector QA/RAScion Medical Technologies, LLCAddress: Scion Medical Technologies, LLC90 Oak StreetNewton, MA 02464U.S.A.Telephone: (617) 209-5629Fax: (888) 963-9112E-mail: chris@scionmedtech.com
Date Prepared:	28 March 2014
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
PredicateDevice:	Beacon Tissue Marker K130763 May 8th, 2013
DeviceDescription:	The proposed Beacon Tissue Marker consists of a radiographicsoft tissue marker and the delivery system. The proposedBeacon Tissue Marker is a sterile, single patient use, PEKKdiscrete marker 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 BariumSulfate (Polyetherketoneketone with 20% BaSO4 by wt%).OXPEKK-IG200 is a radiolucent material and serves as the carrierfor the radiopaque BaSO4.
	single patient use, pre-loaded delivery system incorporating theBeacon Tissue Marker. The delivery system consists of acannula with a handle, a push rod with a plunger, tabs to retainthe tissue marker, and a tip cover. The tissue marker is retainedwithin the delivery system until placement is desired, where it isdelivered through the end port by fully depressing the plunger intothe handle. The Beacon Tissue Marker delivery system is used toplace the Beacon Tissue Marker into soft tissue during open,percutaneous, or endoscopic procedures to radiographically marka surgical location. The delivery system device has a beveled12 cm / 14 gauge needle with 1 cm depth marks and a plunger.
Indications forUse:	The Beacon Tissue Marker is indicated for use to radiographicallymark soft tissue during a surgical procedure or for future surgicalprocedures.
TechnologicalCharacteristics:	The designs of the predicate and proposed Beacon TissueMarkers are the same. Both devices use the same PEKK tissuemarker, with the same geometry, and a 20% BaSO4 loading. Thedelivery systems are also functionally equivalent. The materialsare the same and the plunger/cannula deployment mechanismsare the same. Overall length and system features are equivalent.Both devices employ a retention mechanism to retain the markerin the delivery system. The predicate delivery system uses avestamid sleeve retention mechanism that is bonded to the ID ofthe cannula. The proposed device uses two tabs that areprecision laser cut into the distal tip of the stainless steel cannulathat are bent inward to create a narrowed section in the cannulabody to retain the marker.
Non-ClinicalTesting:	Substantial equivalence of the proposed device was determinedthrough functional, deployment, and package integrity testing.Specifically, testing included deployment force, marker expulsion,component bond strength, marker retention, dimensional, pouchpeel, and pouch leak. All testing met pre-defined acceptancecriteria.
Conclusion:	In summary, Scion Medical Technologies, LLC believes that theproposed Beacon Tissue Marker, as described in this submission,does not raise any new or significant questions of safety andefficacy and is substantially equivalent to the predicate ScionMedical Technologies, LLC Beacon Tissue Marker (K130763)cleared on May 8th, 2013 which is comprised of the Kent MedicalDevices, Inc. KMD-Mark1 Tissue Marker (K093473), which wasdetermined to be substantially equivalent and cleared on July 02,2010, and the Carbon Medical Technologies, Inc. BiomarC TissueMarker (K063193), which was determined to be substantiallyequivalent 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

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Page 2 - Mr. Chris Lewis

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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

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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)

PSC Publuiting Scrices (301) 443-6740

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.