(98 days)
Not Found
No
The summary describes a mechanical biopsy needle and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No.
This device is designed for diagnostic purposes (biopsy) and to provide access to a surgical site, not to treat a disease or condition.
Yes
Justification: The "Device Description" explicitly states "This device can be used as a standalone device to remove a sample of bone tissue from a vertebral body or bone for diagnostic purposes".
No
The device description explicitly details physical components like cannulas and needles with specific sizes and lengths, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
- Device Function: This device is a surgical instrument used within the body to obtain a tissue sample (bone or vertebral body). It is not used to analyze or test the sample itself.
- Intended Use: The intended use clearly states it's for a physician performing a biopsy using the device to remove a sample.
- Device Description: The description focuses on the physical characteristics of the needle and cannula used for the biopsy procedure.
While the sample obtained using this device will likely be sent to a laboratory for in vitro diagnostic testing, the device itself is the tool for collecting the sample, not the tool for performing the diagnostic test.
N/A
Intended Use / Indications for Use
This device is intended for use by a physician performing a bone or vertebral body biopsy using a coring, cutting, or aspiration technique.
Product codes
KNW
Device Description
This device can be used as a standalone device to remove a sample of bone tissue from a vertebral body or bone for diagnostic purposes using a coring, cutting or aspiration technique for diagnostic purposes as well as to provide and maintain access to the same surgical site. The access cannula sizes are 8, 11 and 13 gauge with coaxial needle of 11, 14, and 15.5 gauges. The needle lengths are 19 and 22 cm. This product is a single use, sterile prescriptive device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone or vertebral body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician
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)
All materials used in the fabrication of the Coaxial Bone and Vertebral Body Biopsy Needle were evaluated through biological qualification safety tests as outlined in ISO 10993 Part-1 "Biological Evaluation of Medical Devices". These materials also were tested in accordance with industry recognized test methods and were found to be acceptable for the intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K07-0091
pg 1 of 2
Cardinal Health
1430 Waukegan Road
McGaw Park, Illinois 60085-6787
McGaw Park, Illinois 60085-6787
FAX: 847.578.66 10
FAX: 847.785.2506
CardinalHealth
APR 1 8 2007
SMDA REQUIREMENTS
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Coaxial Bone and Vertebral Body Biopsy Needle
| Sponsor: | Cardinal Health
1430 Waukegan Road MPKB
McGaw Park, IL 60085 |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory Affairs
Contact: | Sharon Nichols |
| Telephone: | (847) 578-6610 |
| Date Summary Prepared: | March 2007 |
| Common Name: | Coaxial Bone and Vertebral Body
Biopsy Needle |
| Classification: | Class II per 21CFR §876.1075 |
| Predicate Devices: | Cardinal Health Jamshidi Coaxial
Bone Biopsy Needle, (K813338)
Stryker Bone and Vertebral Body
Biopsy Kit (K032943) |
| Description: | This device can be used as a
standalone device to remove a sample
of bone tissue from a vertebral body or
bone for diagnostic purposes using a
coring, cutting or aspiration technique
for diagnostic purposes as well as to
provide and maintain access to the
same surgical site. |
| | The access cannula sizes are 8, 11 and
13 gauge with coaxial needle of 11, 14,
and 15.5 gauges. The needle lengths
are 19 and 22 cm. This product is a
single use, sterile prescriptive device. |
1
pg 2 of 2
Image /page/1/Picture/2 description: The image shows the logo for Cardinal Health. The logo consists of three curved lines above the company name. The company name is written in a sans-serif font, with the word "Cardinal" in a bold font and the word "Health" in a regular font.
Cardinal Health
1430 Waukegan Road
McGaw Park, Illinois 60085-6787
847.578.6610 FAX: 847.785.2506
SMDA REQUIREMENTS (continued)
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
Coaxial Bone and Vertebral Body Biopsy Needle
| Intended Use: | This device is intended for use by a physician
performing a bone or vertebral body biopsy
using a coring, cutting, or aspiration technique. |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Substantial Equivalence: | The Coaxial Bone and Vertebral Body
Biopsy Needle is substantially equivalent
to the Cardinal Health Coaxial Bone
Biopsy Needle and the Stryker Bone and
Vertebral Body Biopsy Kit in that the
intended use and the performance
attributes are equivalent. |
| Summary of
Testing: | All materials used in the fabrication of the
Coaxial Bone and Vertebral Body Biopsy
Needle were evaluated through biological
qualification safety tests as outlined in ISO
10993 Part-1 "Biological Evaluation of Medical
Devices". These materials also were tested in
accordance with industry recognized test
methods and were found to be acceptable for
the intended use. |
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the department's name arranged in a circular pattern around a stylized caduceus symbol. The caduceus is depicted with a staff entwined by a serpent, representing health and medicine. The seal is in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Cardinal Health, Inc. % Ms. Sharon Nichols Regulatory Affairs Manager 1430 Waukegan Road McGaw Park, Illinois 60085
APR 1 8 2007
Re: K070091
Trade/Device Name: Coaxial Bone and Vertebral Body Biopsy Needle Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: II Product Code: KNW Dated: March 12, 2007 Received: March 13, 2007
Dear Ms. Nichols:
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.
3
Page 2 - Ms. Sharon Nichols
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely your
five Dblmy
Mark N. Mellekerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
pg 1 of 1
Image /page/4/Picture/2 description: The image shows the logo for Cardinal Health. The logo consists of the company name, "CardinalHealth", in a bold, sans-serif font. Above the name is a graphic element that appears to be a stylized representation of lines or a network.
1430 Waukegan Road McGaw Park, Illinois 60085-6787 847.578.6610 6 847 785 2506
Page 1 of 1
510(k) Number (if known):
Device Name:
Coaxial Bone and Vertebral Body Biopsy Needle
Indications For Use:
This device is intended for use by a physician performing a bone or vertebral body biopsy using a coring, cutting, or aspiration technique.
Prescription Use X and/or (Part 21 CFR 801 Subpart D)
Over-The Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number | K070051