The BiomarC Coaxial Needle is a sterile, pyrogen free, single patient use, disposable coaxial needle that consists of an outer cannula with an attached female luer lock hub, an inner stylet with an attached male luer lock hub, and a flexible slip ring style depth stop. The BiomarC Coaxial Needle is designed for use with BiomarC Fiducial Markers. The outer cannula is only one gauge size larger than the appropriate BiomarC Fiducial Marker needle, e.g., 18g BiomarC Coaxial Needle for a 19g BiomarC Fiducial Marker needle.

AI/ML Overview

This document is not a study, but rather a 510(k) Premarket Notification for a medical device (BiomarC Coaxial Needle). It doesn't contain information about a clinical study with acceptance criteria and reported device performance in the way a traditional clinical trial report would. Instead, it focuses on demonstrating substantial equivalence to predicate devices.

Therefore, many of the requested fields regarding acceptance criteria, study design, sample sizes, experts, and ground truth are not applicable or cannot be extracted from this type of document.

However, I can extract information related to the device's intended performance and how its characteristics are compared to predicate devices, which implicitly serves as the basis for its safety and effectiveness claims for regulatory purposes.

Here's a breakdown of what can and cannot be extracted:

1. A table of acceptance criteria and the reported device performance

This document does not present explicit "acceptance criteria" and "reported device performance" in the context of a clinical study with measured outcomes against predefined thresholds. Instead, it relies on demonstrating that the proposed device has technological characteristics and performance substantially equivalent to legally marketed predicate devices.

The table below summarizes the comparison between the proposed device and its predicates, which serves as the implicit "proof" of meeting performance expectations for substantial equivalence.

Characteristic	Acceptance Criteria (Implicit by Equivalence to Predicates)	Reported Device Performance (as stated for the proposed device)
Primary Performance Feature	Ability to create a channel through soft tissue Ability to allow delivery of injectable materials (for predicate) or guide another device (for predicate)	Able to create a channel through soft tissue Able to allow delivery of fiducial markers through channel created
Indications for Use	To allow delivery of injectable materials into tissue during an endoscopic procedure (P1) To be used as a guiding needle in obtaining core, biopsy samples (P2)	To allow delivery of fiducial markers into soft tissue.
Use	Single use (matching predicates)	Single use
Sterility	Sterilized by EO with an SAL of 1x10-6 (matching P1) or Sterilized by EO (matching P2)	Sterilized by EO with an SAL of 1x10-6
Pyrogens	Pyrogen free (matching predicates)	Pyrogen free
Cannula/Stylet Material	Stainless steel, type 304 (for proposed device, matching general "stainless steel" for predicates)	Stainless steel, type 304
Tip Style	Trocar tip or Spinal tip (P1) or Trocar or blunt tip (P2)	Trocar tip
Biocompatibility/Safety	Safety established through history of use of similar devices for identical nature and duration of patient contact (matching P1, P2 unknown but implied by predicate use)	Safety has been established for the identical nature and duration of patient contact through a history of use in other similar devices.

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

Sample Size: Not applicable. This document does not describe a test set or comparative study with specific sample sizes. The submission relies on a comparison of technological characteristics to predicate devices already on the market.
Data Provenance: Not applicable. The "study" here is a regulatory submission demonstrating substantial equivalence, not a clinical trial.

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

Not applicable. There was no "test set" requiring ground truth established by experts in the context of a performance study.

4. Adjudication method for the test set

Not applicable. There was no "test set" requiring adjudication.

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 is not an AI/software device and no MRMC study was performed or described.

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

Not applicable. This is a physical medical device (coaxial needle), not an algorithm or AI.

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

Not applicable. There was no "ground truth" in the clinical study sense. The "ground truth" for the device's acceptability is its substantial equivalence to legally marketed devices, implying that their established safety and effectiveness applies to the new device given its similar characteristics and intended use.

8. The sample size for the training set

Not applicable. As this is a physical medical device and not an AI/machine learning algorithm, there is no concept of a "training set."

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

Not applicable. See point 8.

Summary

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510(k) Summary 5

5. 510(k) Summary

5 -

ं . . .

Andrew Adams Director - Regulatory Affairs & Quality Assurance Carbon Medical Technologies, Inc. 1290 Hammond Road Saint Paul, MN 55110

651-653-8512 Phone: Fax: 651-407-1975

Submitted: September 27, 2013

Device Name

Trade Name:	BiomarC Coaxial Needle
Classification Name:	Endoscopic Injection Needle, 21 CFR 876.1500, FBK
	Implantable Clip, 21 CFR 878.4300, NEU
Common/Usual Name:	Coaxial Needle

Predicate Devices

Carbon Medical Technologies Endoscopic Injection Needle (K042615), by Carbon Medical Technologies, Inc. Coaxial Biopsy Needle (K936194), by Bard Gynecology & Radiology

Indication for Use

The BiomarC Coaxial Needle allows delivery of fiducial markers into soft tissue.

Device Description

The BiomarC Coaxial Needle is designed for use with BiomarC Fiducial Markers. The outer cannula is only one gauge size larger than the appropriate BiomarC Fiducial Marker needle, e.g., 18g BiomarC Coaxial Needle for a 19g BiomarC Fiducial Marker needle.

BiomarC Coaxial Needle Premarket Notification 510(k) 5-1 (May 8, 2014)

MAY 1 3 2014

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Technological Characteristics and Performance

ﺎ

The technological characteristics and performance of the BiomarC Coaxial Needle are substantially equivalent to the predicate devices (Table 5).

Characteristic	Proposed Device	Predicate Device	Predicate Device
Trade name	BiomarC Coaxial Needle	Carbon MedicalTechnologies EndoscopicInjection Needle	Coaxial Biopsy Needle
510(k) number		K042615	K936194
510(k) holder	Carbon MedicalTechnologies, Inc.	Carbon MedicalTechnologies, Inc.	Bard Gynecology andRadiology
Indications foruse	The BiomarC CoaxialNeedle allows delivery offiducial markers into softtissue.	The Carbon MedicalTechnologies InjectionNeedle is an accessory forcurrently marketedendoscopes to allowdelivery of injectablematerials into tissue duringan endoscopic procedure.	The coaxial biopsy needleguide is intended for use asa guiding needle inobtaining core, biopsysamples from soft tissuesuch as liver, kidney,spleen, lymph nodes andvarious soft tissue lesions.
Use	Single use	Single use	Single use
Sterility	Sterilized by EO with anSAL of 1x10-6	Sterilized by EO with anSAL of 1x10-6	Sterilized by EO
Pyrogens	Pyrogen free	Pyrogen free	Pyrogen free
Cannula/styletrod material	Stainless steel, type 304	Stainless steel	Stainless steel
Tip style	Trocar tip	Spinal tip	Trocar or blunt tip
Device bodycontactcategory	External communicatingdevice, tissue, limited	External communicatingdevice, tissue, limited	External communicatingdevice, tissue, limited
Safety	Safety has been establishedfor the identical nature andduration of patient contactthrough a history of use inother similar devices.	Safety has been establishedfor the identical nature andduration of patient contactthrough a history of use inother identical and similardevices.	Unknown
	Able to create a channelthrough soft tissue	Able to create a channelthrough soft tissue	Able to create a channelthrough soft tissue
Performance	Able to allow delivery offiducial markers throughchannel created	Able to allow delivery ofinjectable materials throughchannel created	Able to guide anotherdevice through channelcreated

BiomarC Coaxial Needle Premarket Notification 510(k) 5-2 (May 8, 2014)

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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 depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

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 13, 2014

Carbon Medical Technologies Incorporated Mr. Andrew J. Adams Director, Regulatory Affairs & Quality Assurance 1290 Hammond Road Saint Paul, Minnesota 55110

Re: K133148

Trade/Device Name: BiomarC Coaxial Needle Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: FBK, NEU Dated: March 6, 2014 Received: March 7, 2014

Dear Mr. Adams:

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

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Page 2 - Mr. Andrew J. Adams

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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

David Krause -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. for . Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

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Indications for Use Statement

510(k) Number: K133148

Device Name: BiomarC Coaxial Needle

Indications for Use:

The BiomarC Coaxial Needle allows delivery of fiducial markers into soft tissue.

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)

Joshua C. Nipper -S

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BiomarC Coaxial Needle Premarket Notification 510(k) 4-1 (May 8, 2014)

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.