(98 days)
This device is intended for use by a physician performing a bone or vertebral body biopsy using a coring, cutting, or aspiration technique.
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.
This document describes the Coaxial Bone and Vertebral Body Biopsy Needle. It is a medical device intended for use by a physician to perform bone or vertebral body biopsies using coring, cutting, or aspiration techniques.
Here is the information about its acceptance criteria and the study:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility: Materials must be acceptable for contact with the human body. | All materials used in fabrication were evaluated through biological qualification safety tests as outlined in ISO 10993 Part-1 "Biological Evaluation of Medical Devices" and found to be acceptable for the intended use. |
| Performance Attributes: The device must demonstrate equivalent performance to its predicate devices. | The device's performance attributes were determined to be equivalent to the Cardinal Health Jamshidi Coaxial Bone Biopsy Needle (K813338) and the Stryker Bone and Vertebral Body Biopsy Kit (K032943). |
| Industry Recognized Test Methods: Testing must be performed in accordance with industry-recognized methods. | Materials were tested in accordance with "industry recognized test methods." |
| Intended Use: Device must be suitable for its stated intended use. | The device is intended for use by a physician performing a bone or vertebral body biopsy using a coring, cutting, or aspiration technique, and testing confirmed its suitability for this purpose. |
| Substantial Equivalence: The device must be substantially equivalent to legally marketed predicate devices. | The FDA reviewed the 510(k) and determined the device is substantially equivalent to its predicate devices. |
2. Sample Size Used for the Test Set and the Data Provenance
The summary states that "All materials used in the fabrication... were evaluated," and "These materials also were tested." However, it does not specify the sample size of materials tested or the specific number of devices tested. It also does not explicitly state the data provenance (e.g., country of origin or whether the data was retrospective or prospective). The testing appears to be primarily laboratory-based material and performance testing rather than clinical data from human subjects.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This type of information is not typically applicable for a device like a biopsy needle, where "ground truth" often refers to clinical diagnoses or outcomes. The testing described focuses on material properties and device performance characteristics against established benchmarks and predicate devices, not on diagnostic accuracy requiring expert panel review. Therefore, no information on experts establishing ground truth for a test set is provided.
4. Adjudication Method for the Test Set
Not applicable, as this device's testing relates to material properties and performance rather than diagnostic accuracy that would typically involve adjudication of clinical data.
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
Not applicable. This device is a manual biopsy needle, not an AI-powered diagnostic or imaging tool, so MRMC studies involving human readers and AI assistance are not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a manual surgical instrument, not an algorithm, so standalone algorithm performance testing is not relevant.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The "ground truth" in this context is based on:
- Established Material Standards: Compliance with ISO 10993 Part-1 for biocompatibility.
- Industry Recognized Test Methods: Performance against generally accepted test protocols for medical device materials and functionality.
- Predicate Device Performance: Equivalence to the performance attributes of previously cleared predicate devices (Cardinal Health Jamshidi Coaxial Bone Biopsy Needle and Stryker Bone and Vertebral Body Biopsy Kit).
8. The Sample Size for the Training Set
Not applicable. This device is a physical medical instrument, not an AI/machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
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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 Health1430 Waukegan Road MPKBMcGaw Park, IL 60085 |
|---|---|
| Regulatory AffairsContact: | Sharon Nichols |
| Telephone: | (847) 578-6610 |
| Date Summary Prepared: | March 2007 |
| Common Name: | Coaxial Bone and Vertebral BodyBiopsy Needle |
| Classification: | Class II per 21CFR §876.1075 |
| Predicate Devices: | Cardinal Health Jamshidi CoaxialBone Biopsy Needle, (K813338)Stryker Bone and Vertebral BodyBiopsy Kit (K032943) |
| Description: | This device can be used as astandalone device to remove a sampleof bone tissue from a vertebral body orbone for diagnostic purposes using acoring, cutting or aspiration techniquefor diagnostic purposes as well as toprovide and maintain access to thesame surgical site. |
| The access cannula sizes are 8, 11 and13 gauge with coaxial needle of 11, 14,and 15.5 gauges. The needle lengthsare 19 and 22 cm. This product is asingle use, sterile prescriptive device. |
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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 physicianperforming a bone or vertebral body biopsyusing a coring, cutting, or aspiration technique. |
|---|---|
| Substantial Equivalence: | The Coaxial Bone and Vertebral BodyBiopsy Needle is substantially equivalentto the Cardinal Health Coaxial BoneBiopsy Needle and the Stryker Bone andVertebral Body Biopsy Kit in that theintended use and the performanceattributes are equivalent. |
| Summary ofTesting: | All materials used in the fabrication of theCoaxial Bone and Vertebral Body BiopsyNeedle were evaluated through biologicalqualification safety tests as outlined in ISO10993 Part-1 "Biological Evaluation of MedicalDevices". These materials also were tested inaccordance with industry recognized testmethods and were found to be acceptable forthe intended use. |
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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.
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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
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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
§ 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.