Beacon Tissue Marker (SE) is indicated for use to radiographically mark soft tissue at the surgical site during a surgical procedure or for future procedures.

Device Description

The Beacon Tissue Marker (SE) consists of a radiographic soft tissue marker and the delivery system. The Beacon Tissue Marker (SE) 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 an additional offering of a delivery system with radiused tip and increased rod length corresponding to the new radius tip. The delivery system is sterile, single patient use, and is pre-loaded incorporating the tissue marker. The delivery system has a radius tip 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.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the "Beacon Tissue Marker (SE)". It does not describe a study involving an AI algorithm or digital health product. Instead, it is a submission for a physical implantable clip used to mark soft tissue. Therefore, many of the requested elements for an AI/digital health product study are not applicable to this document.

However, I can extract information related to the device and its claimed "substantial equivalence" to predicate devices, which serves a similar purpose to acceptance criteria and a study for traditional medical devices.

Here's the information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Note: For a physical medical device submission like this, "acceptance criteria" are typically met by demonstrating substantial equivalence to a legally marketed predicate device, rather than specific performance metrics against pre-defined thresholds as would be common for an AI algorithm. The performance is assessed by comparing key characteristics to the predicate.

Characteristic / "Acceptance Criteria" (Implicit for Substantial Equivalence)	Reported Device Performance (Beacon Tissue Marker (SE))
Intended Use (Same as predicate)	Indicated for use to radiographically mark soft tissue at the surgical site during a surgical procedure or for future procedures. The proposed device has the same indications for use as the predicate device.
Technological Characteristics	- Same operational technology - Same basic design - Same component materials - Same sterilization method and sterility assurance level - Same packaging materials
Performance Characteristics and Results (Compared to Predicate)	The proposed device has the same performance characteristics and results as the predicate device.
Radiographic Visibility (Same as predicate)	Visible on standard radiographs (x-ray, mammography), ultrasound, and Magnetic Resonance Imaging (MRI) at up to 3.0 Tesla field strength.
Delivery System Cannula Tip (Compared to relevant predicate)	Radiused tip. This specific change is compared to the SenoRx, Inc. StarchMark® Breast Tissue Marker (K131654), which also has an applicator tip with a radius.
Delivery System Rod Length	Increased rod length corresponding to the new radius tip.

2. Sample size used for the test set and the data provenance

Not applicable. This document describes a physical medical device (tissue marker) and its delivery system. The "study" here is a demonstration of substantial equivalence through comparison of design, materials, and intended use to existing predicate devices, rather than a clinical study with a "test set" of data or patient samples in the context of an AI/digital health product.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. See answer to #2.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. See answer to #2.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a physical tissue marker, not an AI or imaging diagnostic tool that would involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithm or software device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. For this type of device, the "ground truth" for demonstrating substantial equivalence primarily relies on engineering specifications, material properties, manufacturing processes, and comparison to the established performance and safety profile of legally marketed predicate devices, rather than clinical outcomes or diagnostic accuracy measurements.

8. The sample size for the training set

Not applicable. See answer to #2.

9. How the ground truth for the training set was established

Not applicable. See answer to #2.

Summary of the document's relevance to "proving acceptance criteria":

The provided document is a 510(k) "Special" submission for a modification to an already cleared device, the Beacon Tissue Marker. The "proof" that the device meets its "acceptance criteria" (which in this context means proving substantial equivalence to predicate devices) is provided through a comparison and discussion (Section G of the Special 510(k) Summary) and by demonstrating compliance with Design Controls and relevant standards (Section H).

The key argument for substantial equivalence is that the proposed Beacon Tissue Marker (SE) has the same indications for use and technological characteristics as its primary predicate (Beacon Tissue Marker K140835). The specific change is a radiused tip and increased rod length on the delivery system, which is deemed substantially equivalent to the delivery system of another predicate device (SenoRx, Inc. StarchMark® Breast Tissue Marker K131654).

This regulatory pathway relies on the existing safety and effectiveness profiles of the predicate devices, rather than entirely new studies for every aspect of the modified device.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, layered on top of each other. The profiles are simple and abstract, with only the outline of the face and neck visible. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Scion Medical Technologies, LLC Mr. Louis Li Quality Assurance/Regulatory Affairs Manager 4613 West Chester Pike Newtown Square, Pennsylvania 19073

December 17, 2015

Re: K153189

Trade/Device Name: Beacon Tissue Marker (SE) Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: Class II Product Code: NEU Dated: October 3, 2015 Received: November 3, 2015

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-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

{1}------------------------------------------------

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.

For

Sincerelv vours.

Joshua C. Nipper -S

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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K153189

Device Name

Beacon Tissue Marker (SE)

Indications for Use (Describe)

Beacon Tissue Marker (SE) is indicated for use to radiographically mark soft tissue at the surgical site during a surgical procedure or for future procedures.

Type of Use ( Select one or both, as applicable )
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Special 510(k) Summarv as required by 21 CFR 807.92(a)

A) Submitted by:	Scion Medical Technologies, LLC
	4613 West Chester PikeNewtown Square, Pennsylvania 19073USA
Official Contact:	Louis Li QA/RA Manager
B) Common name:	Implantable Clip
Proprietary Name:	Beacon Tissue Marker (SE)
Device Class:	Class II, 21 CFR 878.4300
Regulation andClassification 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:	October 23, 2015

E) Device Description

F) Intended Use/Indications For Use:

The Beacon Tissue Marker (SE) is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures

{4}------------------------------------------------

G) Substantial Equivalence Comparison and Discussion

The proposed Beacon Tissue Marker (SE) has the same indications for use and technological characteristics as the predicate device. The proposed and predicate devices have the same:

intended use ●
operational technology ●
. . basic design
component materials
sterilization method and sterility assurance level
packaging materials
performance characteristics and results

The delivery device cannula tip of proposed Beacon Tissue Marker (SE) is radiused and it is substantially equivalent to the delivery device applicator tip of SenoRx, Inc. StarchMark® Breast Tissue Marker cleared on Jun 27 tt, 2013 (K131654).

In summary. Scion Medical Technologies, LLC believes that the proposed changes in Beacon Tissue Marker (SE) Delivery Device, 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) and SenoRx, Inc. StarchMark® Breast Tissue Marker cleared on Jun 27th, 2013 (K131654)

H) Compliance with Design Controls

The results of assessment of the change to the delivery device, conducted under Design Controls, support that the new offering is substantially equivalent to the predicate device delivery system.

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

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.