(293 days)
Not Found
No
The summary describes a mechanical bone marrow aspiration and biopsy system and does not mention any AI or ML components.
No
The devices are used for aspiration, harvest, and biopsy of bone marrow material, which are diagnostic or collection procedures, not therapeutic interventions.
No
This device is used for aspiration/collection and biopsy of bone marrow material, which are procedures to obtain samples. It does not perform the analysis or diagnosis of the sample; rather, it is a tool for sample acquisition.
No
The device description clearly outlines physical components (cannula needle system in various lengths) and mentions the use of a surgical drill "power driver," indicating it is a hardware device.
Based on the provided information, no, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the devices are for the aspiration or harvest and biopsy of bone marrow material in the human body. This is a procedure performed on the patient to collect a sample.
- Device Description: The description details cannula needle systems used for insertion into bone. These are tools for sample collection, not for testing the sample itself.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze or test the collected bone marrow sample. IVD devices are designed to perform tests on biological samples to provide diagnostic information.
These devices are tools for collecting biological samples, which are then typically sent to a laboratory for in vitro diagnostic testing. The devices themselves are not performing the diagnostic test.
N/A
Intended Use / Indications 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.
Product codes (comma separated list FDA assigned to the subject device)
KNW, FCG
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Bio-MAC: Proximal Humerus, Proximal Tibia, Posterior Illiac Crest, Anterior Iliac Crest and Vertebral Body
Bio-CORE: Iliac Crest
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Testing:
- 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
Results: 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 effective as the predicate device thus the Bio-MAC and Bio-CORE are recognized to be substantially equivalent.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in all caps. The text is in a bold, sans-serif font. The words are arranged on a single line and are centered horizontally. The text is likely part of a document or presentation related to the Department of Health and Human Services.
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird with outstretched wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the bird image.
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
1
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 Administration | |||
| Indications for Use | Expiration Date: January 31, 2017 | ||
| See 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. | |||
| 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
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-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
4
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 Marrow
Biopsy 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 Fenestration
Slots | Yes | No |
| Packaged Sterilized | Yes | Yes |
| Single Use Device | Yes | Yes |
| Method of Device
Insertion | Drill / Driver; via a
provided driver adapter -
customer owned drill -
example Stryker Surgical
Instruments and
Accessories - K943323 | Drill / Driver; via a provided re-
useable battery powered drill |
| Method of aspiration | Attached syringe to Luer
Lock on cannula hub | Attached syringe to Luer Lock
on cannula hub |
| Skeletal Location of Use | Proximal Humerus,
Proximal Tibia, Posterior
lliac Crest, Anterior Iliac
Crest and Vertebral Body | Proximal Humerus, Proximal
Tibia, Distal Tibia and Iliac
Crest |
6
| Device Characteristic | Biologics Therapies | Vidacare
ా నిర్ణించ |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------|
| Device Name | Bio-CORE | Oncontrol Bone Marrow Biopsy
System |
| 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 Device
Insertion | Drill / Driver; via a
provided driver adapter -
customer owned drill -
example Stryker Surgical
Instruments and
Accessories - 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
7
effective as the predicate device thus the Bio-MAC and Bio-CORE are recognized to be substantially equivalent.
i