The Bio-CORE™ Bone Marrow Biopsy Cannula System is for use in the intraosseous harvest and biopsy of "solid core" bone marrow material in the human body.

Device Description

The Bio-MAC™ Bone Marrow Aspiration Cannula System is an 11 gauge cannula needle system in various lengths (currently 25,45,60,80 and 105mm) that allows the use of a surgical drill "power driver" for hard bone insertion during a viscous bone marrow aspiration/collection procedure.

The Bio-CORE™ Bone Marrow Biopsy Cannula is an 11guage cannula needle system in various lengths (currently of 60, 80, and 105mm) that allows the use of a surgical drill "power driver" for hard bone insertion during a bone marrow solid core biopsy procedure.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Bio-MAC™ and Bio-CORE™ Intraosseous Cannula Systems. It establishes substantial equivalence to a predicate device, the ONCONTROL Bone Marrow Biopsy System (K072045), based on technological characteristics and performance testing.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a numerical or categorical format with pass/fail thresholds. Instead, it relies on demonstrating substantial equivalence to the predicate device through comparisons of design characteristics and performance testing. The "reported device performance" is essentially a statement that the devices functioned as safe and effective as the predicate.

Characteristic/Test	Acceptance Criteria (Implied)	Reported Device Performance
Indications for Use	In line with predicate device	"No Deviations - The submitted devices indications are in line with the predicate device."
Needle Design (Material/Gauge)	Similar to predicate device	Bio-MAC and Bio-CORE use 304 Stainless Steel / Polyetherimide (Ultem); 11 gauge. Predicate uses 304 Stainless Steel; 11 gauge.
Technique	Similar to predicate device	Implied to be similar based on device descriptions (power drill insertion, syringe aspiration/biopsy).
Sterility	Packaged sterilized, similar to predicate	Both submitted devices and predicate are Packaged Sterilized.
Single Use	Single use, similar to predicate	Both submitted devices and predicate are Single Use Device.
Anatomical Location	Similar to predicate	Bio-MAC: Proximal Humerus, Proximal Tibia, Posterior Iliac Crest, Anterior Iliac Crest, Vertebral Body. Predicate: Proximal Humerus, Proximal Tibia, Distal Tibia, Iliac Crest. (Overlap exists, some differences noted but deemed equivalent). Bio-CORE: Iliac Creat. Predicate: Iliac Crest.
Method of Device Insertion	Drill/Driver, functionally equivalent	Submitted devices use customer-owned drill via adapter. Predicate uses provided reusable battery-powered drill. Deemed equivalent.
Method of Aspiration	Attached syringe to Luer Lock, similar to predicate	Both submitted devices and predicate use Attached syringe to Luer Lock on cannula hub.
Physical Testing (Torque/Pullout)	Perform as safe and effective as the predicate device	"The results indicated the submitted devices perform as safe and effective as the predicate device."

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

The document indicates that bench testing was performed.

Sample Size for Test Set: "Utilizing a predicate device of the largest size and the BTI Bio-MAC and Bio-CORE smallest and largest size bench testing was accomplished." This implies a limited number of devices were tested (at least one of each specified size for the submitted devices and one largest size for the predicate). A specific numerical sample size is not provided.
Data Provenance: The document does not explicitly state country of origin for the data or whether it was retrospective or prospective. Given it's bench testing conducted for a premarket submission, it would be considered prospective data generated for the submission.

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

The document does not mention using experts or establishing ground truth in the context of clinical studies, as the performance testing described is bench testing.

4. Adjudication Method for the Test Set

As the performance testing described is bench testing, there is no mention of an adjudication method.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed or described in this document. The submission relies on bench testing and comparison of technological characteristics to a predicate device.

6. Standalone (Algorithm Only) Performance Study

Not Applicable. This device is an intraosseous cannula system, a physical medical device, not an algorithm or AI system. Therefore, a standalone (algorithm only) performance study was not conducted or described.

7. Type of Ground Truth Used

The concept of "ground truth" as typically applied in AI/image analysis (e.g., pathology, expert consensus) does not directly apply to the bench testing described for this physical device. The "truth" for the performance tests would be the measured physical properties (e.g., torque to turn, pullout force) and whether they met engineering specifications or performed comparably to the predicate device.

8. Sample Size for the Training Set

Not Applicable. This document describes the 510(k) submission for a physical medical device, not an AI/ML algorithm. There is no training set involved.

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

Not Applicable. As there is no training set, there is no ground truth establishment for a training set.

Summary

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Public Health Service

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

May 4, 2015

Biologics Therapies Incorporated c/o Mr. Stephen Inglese Quality Solutions and Support, LLC 5817 North West 44th Avenue Ocala. Florida 34482

Re: K141910

Trade/Device Name: Intraosseous Cannula System Bio-MAC™ and Bio-CORE™ Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: Class II Product Code: KNW, FCG Dated: April 24, 2015 Received: April 27, 2015

Dear Mr. Inglese:

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. Stephen Inglese

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,

Jennifer R. Stevenson -S

For 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

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Bio-MAC™ and Bio-CORE ™
Biologic Therapies, Inc.

Biologic Therapies, Inc.

Indications for Use Statement 4.0

DEPARTMENT OF HEALTH AND HUMAN SERVICES		Form Approved: OMB No. 0910-0120
Food and Drug AdministrationIndications for Use		Expiration Date: January 31, 2017See PRA Statement below.
510(k) Number (if known)	K141910
Device Name	Intraosseous Cannula System - Bio-MAC™ and Bio-CORE™
Indications for Use (Describe)
	The Bio-MAC™ Bone Marrow Aspiration Cannula System is for use in the intraosseous aspiration of viscous bone marrow material in the human body.
	The Bio-CORE™ Bone Marrow Biopsy Cannula System is for use in the intraosseous harvest and biopsy of "solid core" bone marrow material in the human body.
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.
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	"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."

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5.0 510(k) Summarv

In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for the Intraosseous Cannula Systems is provided below.

Device Common Name: Biopsy Instrument

Device Proprietary Name: Intraosseous Cannula System Bio-MAC™ and Bio-CORE™

Submitter: Biologics Therapies, Inc. 5817 NW 44th Avenue Ocala. FL 34482 (352)-304-5149
Contact: Stephen Inglese Consultant Quality Solutions and Support, LLC Phone: 561-251-0876 Email: swi@gss-llc.com

Date Prepared:	January 10th 2015
----------------	-------------------

Classification Regulation:	876.1075 - Gastroenterolgy- Urology
	Biopsy Instrument
Panel:	Gastroenterology / Urology
Product Code:	KNW - Subsequent Code: FCG

Predicate Device:	K072045 – ONCONTROL Bone Marrow Biopsy
	System

Indication for Use:

The Bio-MAC™ Bone Marrow Aspiration Cannula System is for use in the intraosseous aspiration of viscous bone marrow material in the human body.

The Bio-CORE™ Bone Marrow Biopsy Cannula System is for use in the intraosseous harvest and biopsy of "solid core" bone marrow material in the human body.

Device Description:

The Bio-CORE™ Bone Marrow Biopsy Cannula is an 11guage cannula needle system in various lengths (currently of 60, 80, and 105mm) that allows

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the use of a surgical drill "power driver" for hard bone insertion during a bone marrow solid core biopsy procedure.

Indication Statement Comparison:

Predicate Device: K072045 - OnControl Bone Marrow Biopsy System Indications - The OnControl Bone Marrow Biopsy System is intended for bone marrow aspiration and biopsy.

Submitted Devices:

Bio-MAC - The Bio-MAC™ Bone Marrow Aspiration Cannula System is for use in the intraosseous aspiration of viscous bone marrow material in the human body.

Bio-MAC - The Bio-CORE™ Bone Marrow Biopsy Cannula System is for use in the intraosseous harvest and biopsy of "solid core" bone marrow material in the human body.

Summary Indication Comparison:

No Deviations - The submitted devices indications are in line with the predicate device. The submitted devices accomplish either bone marrow aspiration or bone marrow biopsy as similarly stated in the predicate indication.

Summary of technological characteristics / Substantial Equivalence-

The predicate and the Intraosseous Cannula Systems Bio-MAC™ and Bio-CORE™ were compared in the following areas and found to have similar technological characteristics and to be equivalent to the Vidacare OnControl Bone Marrow Biopsy System :

Indications for use .
Needle Design (Material and Gauge)
Technique ●
Sterility ●
Single Use ●
Anatomical Location ●

Summaries of technological characteristics demonstrating substantial equivalence (SE) (BTI Bio-MAC and BTI Bio-CORE with SE Vidacare OnControl are also provided below:

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BTI - Bio-MAC device as compared to the Vidacare – OnControl Bone Marrow Biopsy System -

Device Characteristic	Biologics Therapies(BTI)	Vidacare
Device Name	Bio-MAC	OnControl Bone MarrowBiopsy System
510(k) Number	K141910	K072045
Material	304 Stainless Steel /Polyetherimide (Ultem)	304 Stainless Steel
Diameter - gauge	11	11
Length - mm	25, 45, 60, 80, 105mm	25, 60, 90 and 102mm
Cannula FenestrationSlots	Yes	No
Packaged Sterilized	Yes	Yes
Single Use Device	Yes	Yes
Method of DeviceInsertion	Drill / Driver; via aprovided driver adapter -customer owned drill -example Stryker SurgicalInstruments andAccessories - K943323	Drill / Driver; via a provided re-useable battery powered drill
Method of aspiration	Attached syringe to LuerLock on cannula hub	Attached syringe to Luer Lockon cannula hub
Skeletal Location of Use	Proximal Humerus,Proximal Tibia, Posteriorlliac Crest, Anterior IliacCrest and Vertebral Body	Proximal Humerus, ProximalTibia, Distal Tibia and IliacCrest

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Device Characteristic	Biologics Therapies	Vidacareా నిర్ణించ
Device Name	Bio-CORE	Oncontrol Bone Marrow BiopsySystem
510(k) Number	K141910	K072045
Material	304 Stainless Steel /Polyetherimide (Ultem)	304 Stainless Steel
Diameter - mm	11	11
Length - mm	60, 80 and 105mm	102 and 152mm
Packaged Sterilized	Yes	Yes
Single Use Device	Yes	Yes
Method of DeviceInsertion	Drill / Driver; via aprovided driver adapter -customer owned drill -example Stryker SurgicalInstruments andAccessories - K943323	Drill / Driver; via a provided re-useable battery powered drill
Skeletal Location of Use	lliac Crest	lliac Crest

BTI - Bio-CORE device as compared to the Vidacare - OnControl Bone Marrow Biopsy System -

Performance Testing :

To establish the substantial equivalence of the Intraosseous Cannula Systems Bio-MAC™ and Bio-CORE™ devices the following performance tests were performed:

. 027_A6_Bio-MAC Design Validation PROT / RPT 300
028_A6_Bio-CORE Design Validation PROT /RPT 301 ●
029_A6_Predicate Device Testing Bio-MAC Design Validation PROT ● / RPT 301

. 030_A6_Bio-MAC Physical Testing - Torque to Turn and Pullout Tests The results indicated the submitted devices perform as safe and effective as the predicate device.

Performance Testing Summary:

Utilizing a predicate device of the largest size and the BTI Bio-MAC and Bio-CORE smallest and largest size bench testing was accomplished. The two tests demonstrated that utilizing the BTI Bio-MAC and Bio-CORE in an operating condition demonstrated the devices functioned as safe and

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effective as the predicate device thus the Bio-MAC and Bio-CORE are recognized to be substantially equivalent.

Regulation Number and Section

§ 876.1075 Gastroenterology-urology biopsy instrument.

(a)
Identification. A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments 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 (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.