The I-Style Bone Marrow Aspiration Needle with T-Handle consists of a 15G and 18G needle with a triple sharpened atraumatic tip stylet of corresponding size all made of AISI 304 Stainless steel. The needle has an ergonomic grip at whose base a Luer-Lock cone in fitted. The innovative element of the needle is a removable spacer, which indicates the depths the tip can reach. Using a depth stopper, easy adjustment of the needle length, making it easier to reach the tissue to be examined.

AI/ML Overview

The provided document is a 510(k) summary for a medical device (I-Style Bone Marrow Aspiration Needle with T-Handle) seeking clearance for market, not a study report detailing performance against acceptance criteria with patient data. Therefore, many of the requested elements about clinical studies, sample sizes, expert ground truth, and comparative effectiveness (MRMC) cannot be found in this document.

However, I can extract information related to the device's technical characteristics and the types of verification and validation testing performed.

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

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria / Performance Test	Reported Device Performance
Biocompatibility Tests:	Met testing requirements and found acceptable.
Cytotoxicity Test	Met testing requirements and found acceptable.
Intracutaneous Reactivity Test	Met testing requirements and found acceptable.
Performance Tests:	Met testing requirements and found acceptable.
Fastening and perforation of the stylet tip on the needle entry point	Met testing requirements and found acceptable.
Easiness of insertion of the cannula in the sampling area	Met testing requirements and found acceptable.
Capacity testing on the needle handle	Met testing requirements and found acceptable.
Easiness and manageability of the adjustable spacer	Met testing requirements and found acceptable.
Adequacy of the Luer-Lock connector and twisting capacity of the syringe for bone marrow aspiration	Met testing requirements and found acceptable.
Inspection quantity control of the collected sample	Met testing requirements and found acceptable.
Substantial Equivalence to Predicate Device	Concluded to be substantially equivalent.

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

Not provided. This document details engineering and biocompatibility testing, not a clinical study involving a "test set" of patient data.

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

Not applicable/provided. The tests described are laboratory-based and do not involve human experts establishing ground truth for patient data.

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

Not applicable/provided. No clinical test set.

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:

No, an MRMC study was not done. This describes a medical device (needle), not an AI algorithm for diagnosis or interpretation that would involve human readers.

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

Not applicable/provided. This is a physical medical device, not an algorithm.

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

For the biocompatibility tests: Likely validated laboratory standards for cytotoxicity and intracutaneous reactivity.
For the performance tests: Likely engineering specifications and functional requirements for features like stylet fastening, insertion ease, handle capacity, spacer adjustability, Luer-Lock adequacy, and sample collection inspection. The "ground truth" would be whether the device performed as designed and met the pre-defined engineering and safety specifications.
No clinical ground truth (like pathology or outcomes data) was used in the context of a patient-based study.

8. The sample size for the training set:

Not applicable/provided. This document does not describe an AI/ML device with a "training set."

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

Not applicable/provided. As above, no training set.

Summary based on the document:

This 510(k) summary focuses on demonstrating the substantial equivalence of the I-Style Bone Marrow Aspiration Needle with T-Handle to existing predicate devices. This is achieved through:

Technological Characteristics Comparison: Showing the new device has similar characteristics to the predicate, with minor design changes (T-Handle vs. Quick Stylet locking handle).
Biocompatibility Testing: Materials used were evaluated and found acceptable.
Performance Testing: Several functional aspects of the needle were tested (e.g., stylet fastening, insertion ease, handle capacity, spacer manageability, Luer-Lock adequacy, sample inspection) and found acceptable against unstated internal requirements.

The document states that "All materials used... were evaluated through biological qualification safety tests" and "I-Style Bone Marrow Aspiration Needle with T-Handle has been tested for the following performance tests." It concludes that the materials "have met the testing requirements and were found to be acceptable for the intended use," leading to the overall conclusion of substantial equivalence.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Busse Hospital Disposables. The logo is in black and white and features the word "busse" in a stylized font. Below the word "busse" is the phrase "Hospital Disposables" in a smaller, simpler font. The logo is simple and clean, and it is likely used on the company's products and marketing materials.

Telephone:

Fax:

JUN 2 6 2012

KI20002

-510(k)-Summary-

Regulatory Affairs Contact:

Date Summary Prepared:

Product Trade Name:

Common Name:

Predicate Device:

Classification Name:

Muhamad Ansari Busse Hospital Disposables PO Box: 11067 75 Arkay Dr. Hauppauge NY 11788

631-435-4711 Ext: 254

631-435-2849

December 15, 2011

I-Style Bone Marrow Aspiration Needle with T-Handle

Biopsy Instrument

Class II, 21 CFR 876.1075, Product code KNW

I-Style Bone Marrow Aspiration Needle, K061570 J-Style Bone Marrow Biopsy / Aspiration Needle with Snare-It Marrow Acquisition Cannula, K110883, Busse Hospital Disposables

Device Description:

Section 5 Page 1

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Image /page/1/Picture/0 description: The image shows the logo for Busse Hospital Disposables. The logo is in black and features a stylized, bold font. The word "busse" is prominently displayed, with the letters slightly overlapping and having a unique design. Below the main logo, the words "Hospital Disposables" are printed in a smaller, simpler font.

Intended Use:

The I-Style Bone Marrow Aspiration Needle with T-Handle is intended for aspiration of bone marrow.

Technological Characteristics:

The subject device has the same Technological Characteristics as a leqally marketed predicate device. Except for the minor changes in the Design. which is the Quick Stylet locking handle, whereas in our new product is called T-Handle. Both are made out of AISI 304 Stainless Steel and ABS. The Subject device and the predicate device are intended for aspiration of bone marrow.

Summary of Testing:

All materials used in the fabrication of the I-Style Bone Marrow Aspiration Needle with T-Handle were evaluated through biological qualification safety tests.

The biocompatibility tests performed were:

Cytotoxicity Test .
Intracutaneous Reactivity Test .

Summary of Performance Testing:

I-Style Bone Marrow Aspiration Needle with T-Handle has been tested for the following performance tests:

Fastening and perforation of the stylet tip on the 1. needle entry point
Easiness of insertion of the cannula in the sampling 2. area
Capacity Testing on the needle handle 3.
Easiness and manageability of the adjustable 4. spacer
Adequacy of the Luer-Lock connector and twisting 5. capacity of the syringe for bone marrow aspiration
Inspection quantity control of the collected sample ം.

These materials have met the testing requirements and were found to be acceptable for the intended use.

2/3

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Image /page/2/Picture/0 description: The image shows the logo for "busse Hospital Disposables". The word "busse" is in a bold, sans-serif font, with each letter overlapping the next. Below the word "busse" is the phrase "Hospital Disposables" in a smaller, sans-serif font.

Conclusion:

The above statements are accurate representations of the device Busse intents to market. Based on all the testing and comparison Busse believes the subject device is substantially equivalent to the predicate device. All data and information submitted in this premarket notification is truthful and accurate and no material fact has been omitted.

Official Correspondent: Muhammad Asim (Signature)

Muhamad Ansari

(printed name)

3/3

Title: Director of Regulatory Affairs

Date: 5/28/2012

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

JUN 2 6 2012

Busse Hospital Disposables, Incorporated % Mr. Muhamad Ansari Director of Regulatory Affairs 75 Arkay Drive Hauppauge, New York 11788

Re: K120002

Trade/Device Name: I-Style Bone Marrow Aspiration Needle with T-Handle Regulation Number: CFR 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: II Product Code: KNW Dated: May 28, 2012 Received: May 31, 2012

Dear Mr. Ansarir:

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

Image /page/3/Picture/11 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with outstretched wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the bird symbol. The logo is presented in black and white.

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Page 2 – Mr. Muhamad Ansari

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ycm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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 vours.

Erin D. Keith

Fo Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

1120002 510(k) Number (if known):

Device Name: I-Style Bone Marrow Aspiration Needle with T-Handle

The I-Style Bone Marrow Aspiration Needle with T-Handle is intended for Aspiration of Bone Marrow.

Prescription Use X
(Per 21 CFR 801.109)

Over-The-Counter Use

(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH Office of Device Evaluation (ODE)

Neilkp Dedon for mxm
(Division Sign Off)

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K120002

Premarket Notification - Busse Hospital Disposables Section 4 Page 1

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.