(66 days)
Not Found
No
The device description and intended use are purely mechanical, describing a needle for aspiration. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
This device is for aspirating bone marrow or blood, which is a diagnostic or collection procedure, not a therapeutic treatment.
No
The device is used for aspirating bone marrow or blood, which is a collection of a sample, not a diagnosis. The extracted samples may then be used for diagnostic purposes by other devices or tests.
No
The device description clearly outlines physical components (needle, stylets, handle, luer) and their materials and dimensions, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to aspirate bone marrow or autologous blood. This is a procedure to collect a sample from the body.
- Device Description: The device is a needle and stylets designed for the physical act of obtaining a sample.
- Lack of Diagnostic Function: The description does not mention any function related to analyzing the collected sample or providing diagnostic information. IVD devices are used to examine specimens from the body to provide information for diagnosis, monitoring, or screening.
This device is a tool for sample collection, which is a step that might precede an in vitro diagnostic test, but the device itself is not performing the diagnostic function.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
GAA, KNW
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Bone Marrow
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 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.
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.
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[K050795]
Page 1 of 2
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
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.
1
Technological Characteristics
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.
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
4
Indications for Use Statement
510(k) Number (if known):_
Device Name: Imbibe Bone Marrow Aspiration Needle
Indications for Use:
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.
Prescription Use X (Per 21 C.F.R. 801.109) OR
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)