The Imbibe Bone Marrow Aspiration Needle is for use in aspirating Bone Marrow or Autologous blood by use of a syringe. The bone marrow or autologous blood may be combined with bone graft or bone void filler.

Device Description

The Imbibe Bone Marrow Aspiration Needle consists of an 8ga or 11ga needle, trocar tip stylet of corresponding size, and bullet tip stylet of corresponding size. The needle will be manufactured in two lengths measuring 10cm or 15cm from tip to molded handle. A female luer is provided on the molded needle handle to allow aspiration of bone marrow or blood by use of a standard surgical syringe. One version of the 8ga needle provides fenestrated holes on the distal end of the needle. The fenestrated holes in the distal end of the needle are designed to provide more area for bone marrow or blood to enter the needle during aspiration. The bullet tip stylet must be inserted into the needle, after initial needle placement, if repositioning of the needle is required. If required, the needle can be lightly tapped with a surgical hammer for placement.

AI/ML Overview

The provided 510(k) summary for the Imbibe Bone Marrow Aspiration Needle indicates that performance data was collected, but the specific acceptance criteria and detailed study results are not explicitly provided in the publicly available summary.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Established specifications (specifics not provided)	Met all established specifications
Substantial equivalence to predicate devices for bone marrow aspiration (specifics not provided beyond intended use and technological characteristics)	Demonstrated substantial equivalence to predicate devices; no new issues of safety or effectiveness raised; as safe and effective as predicate devices.

Missing Information: The document states that the device "met all of the established specifications" and "mechanical and performance testing verified that the Imbibe Bone Marrow Aspiration Needle is substantially equivalent." However, it does not provide a table or list of what those specific "established specifications" were, nor does it detail the quantitative results of the "mechanical and performance testing."

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

This information is not provided in the document. The summary only generally refers to "Performance testing." It does not mention the type, size, or origin of any test sets.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This information is not applicable and not provided. The device is an aspiration needle; performance testing would typically involve engineering/mechanical tests and possibly pre-clinical (animal) or clinical use cases to assess factors like ease of use, aspiration success rate, and safety, rather than expert-derived ground truth based on image interpretation or similar diagnostic tasks.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. As above, adjudication methods are typically relevant for diagnostic devices that rely on human interpretation of outputs.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

This information is not applicable and not provided. MRMC studies are generally used for diagnostic devices where human readers interpret results. This is a surgical/procedural device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop) Performance Was Done

This is not applicable. The device is a physical medical instrument, not an algorithm or AI system.

7. The Type of Ground Truth Used

This is not explicitly stated as "ground truth." However, given the nature of the device, the "performance data" would likely be based on:

Mechanical and Material Testing: Evaluating tensile strength, torque, bending, fluid flow rates, material biocompatibility, sterility, etc.
Functional Testing: Assessing the ability to aspirate bone marrow or blood effectively in a controlled environment or in preclinical models.
Comparison to Predicate Devices: Benchmarking against the performance characteristics of the K940025, K001132, and K041991 devices.

8. The Sample Size for the Training Set

This information is not applicable and not provided. "Training set" refers to data used to train algorithms, which is not relevant for this physical device.

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

This information is not applicable and not provided. See point 8.

Summary of the Study and Acceptance Criteria (Based on Provided Text):

The 510(k) summary states that "Performance testing provided in the submission indicates that the Imbibe Bone Marrow Aspiration Needle met all of the established specifications. Mechanical and performance testing verified that the Imbibe Bone Marrow Aspiration Needle is substantially equivalent to the predicate devices for bone marrow aspiration and does not raise any new issues of safety and effectiveness."

The "study" that proves the device meets the acceptance criteria is referred to as "Performance testing" and "Mechanical and performance testing." The primary acceptance criterion was demonstrating substantial equivalence to the predicate devices (Manan Medical's Bone Marrow Harvest Needle K940025, Promex's Bone Biopsy Needle K001132, and Isotis Orthobiologics' Aspirex - Bone Marrow Aspiration Kit K041991) in terms of intended use, indications, technological characteristics, principles of operation, and overall safety and effectiveness.

Key takeaway: While the summary confirms that performance testing was performed and the device met its specifications and substantial equivalence requirements, the specific details of these tests, including quantitative acceptance criteria, actual performance values, sample sizes, and methodologies, are not included in this high-level 510(k) summary. Such details would typically be found in the full 510(k) submission document, which is not publicly released in its entirety.

Summary

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[K050795]

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510(k) SUMMARY

IMBIBE Bone Marrow Aspiration Needle

Orthovita, Inc. 45 Great Valley Parkway Malvern, PA 19355

Phone: (610) 407-5211 (610)-640-2603 Facsimile:

Contact Person:	David McIlhenny
	Sr. Vice President, Operations

March 10, 2005 Date Prepared:

Name of Device

Imbibe™ Bone Marrow Aspiration Needle

Common or Usual Name

Aspiration Needle, BMA Needle

Classification Name

Needle, Aspiration and Injection, Disposable (Product Code GAA)

Predicate Devices

510(K) Number	Predicate Description	Manufactured By
K940025	Bone Marrow Harvest Needle	Manan Medical
K001132	Bone Biopsy Needle	Promex
K041991	Aspirex - Bone Marrow Aspiration Kit	Isotis Orthobiologics

Intended Use / Indications for Use

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Technological Characteristics

Performance Data

Performance testing provided in the submission indicates that the Imbibe Bone Marrow Aspiration Needle met all of the established specifications. Mechanical and performance testing verified that the Imbibe Bone Marrow Aspiration Needle is substantially equivalent to the predicate devices for bone marrow aspiration and does not raise any new issues of safety and effectiveness.

Summary Basis for the Finding of Substantial Equivalence

The Imbibe Bone Marrow Aspiration Needle is substantially equivalent to the predicate devices. The Imbibe Bone Marrow Aspiration Needle has the same intended uses and similar indications, technological characteristics and principles of operation. The minor technological differences between the Imbibe Bone Marrow Aspiration Needle and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrates the Imbibe Bone Marrow Aspiration Needle is as safe and effective as the predicate devices. Thus, the Imbibe Bone Marrow Aspiration Needle is substantially equivalent.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 3 - 2005

Orthovita Incorporated C/o Ms. Janice M. Hogan Regulatory Counsel Hogan & Hartson, L.L.P 1835 Market Street, 2811 Floor Philadelphia, Pennsylvania 19103

Re: K050795

Trade/Device Name: Imbibe Bone Marrow Aspiration Needle Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: II Product Code: KNW Dated: March 24, 2005 Received: March 29, 2005

Dear Ms. Hogan:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

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Page 2 - Ms. Janice M. Hogan

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115 . Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Rulida

Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number (if known):_

Device Name: Imbibe Bone Marrow Aspiration Needle

Indications for Use:

Prescription Use X (Per 21 C.F.R. 801.109) OR

Over-The-Counter Use_

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Concurrence of CDRH, Office of Device Evaluation (ODE)

K050795

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.