(22 days)
Clearview Plus Bone and Vertebral Body Biopsy Needles are intended for use by a physician performing bone or vertebral body biopsy using a coring (cutting) or aspiration technique.
The Clearview Bone and Vertebral Body Biopsy Needles consist of a cannula/stylet assembly in 11 and 13 gauge configurations. The needles have a useable length of 4.565 in (11.6 cm).
The modified Clearview Plus Bone and Vertebral Body Biopsy Needles consist of a cannula/stylet assembly and are available in an 11 gauge configuration. The additional components include:
- . 10cc VacLok syringe
- Luer cap .
- 13.5 gauge inner cannula (useable length 5.355 in, 13.6 cm) .
The needles useable length of 4.565 in (11.6 cm) is the same for the original design and for the modified design. The modified product and the original product are both provided sterile and for single use only.
This is a 510(k) summary for a medical device (Clearview Plus Bone and Vertebral Body Biopsy Needles), not a study demonstrating algorithm performance. Therefore, most of the requested information regarding acceptance criteria, study design, and performance metrics for AI/ML devices is not applicable.
The document describes the device, its intended use, and argues for its substantial equivalence to a predicate device (Clearview Bone and Vertebral Body Biopsy Needles, K011206). Substantial equivalence means the device is as safe and effective as a legally marketed device that does not require premarket approval. The "acceptance criteria" here refers to the regulatory criteria for demonstrating substantial equivalence, not performance metrics of an algorithm.
Here's a breakdown of what information can be extracted or inferred based on the provided text, and what cannot:
1. A table of acceptance criteria and the reported device performance
The provided document does not contain quantitative acceptance criteria or performance data in the way one would expect for an AI/ML device. For a 510(k) submission like this, "acceptance criteria" would primarily relate to demonstrating that the new device shares the same intended use, technological characteristics, and safety/effectiveness profiles as a legally marketed predicate device. The "reported device performance" is essentially the finding of "substantial equivalence."
Acceptance Criteria for 510(k) (Inferred for this type of submission):
| Acceptance Criteria Category | "Reported Device Performance" for Substantial Equivalence |
|---|---|
| Intended Use | The device's intended use is identical to the predicate. |
| Design | The device has similar design features to the predicate (cannula/stylet assembly, gauge configuration, usable length). |
| Technological Characteristics | The device uses similar technology as the predicate (e.g., coring or aspiration technique). |
| Safety and Effectiveness | The device is as safe and effective as the predicate. The submission implies this through equivalence in design and technology, and the 510(k) clearance confirms the FDA's agreement. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a 510(k) for a physical medical device, not an AI/ML algorithm that would undergo a test set evaluation. The decision of substantial equivalence is based on comparing the device and its documentation to a predicate, not on clinical performance data from a test set in the context of an algorithm.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. No "ground truth" establishment in the context of an algorithm's performance on a test set is discussed. The "experts" involved would be the FDA reviewers and the manufacturer's regulatory team.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set for algorithm performance.
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 is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical biopsy needle.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No ground truth in the context of an algorithm's performance. The "ground truth" for this submission is that the predicate device is already legally marketed and considered safe and effective.
8. The sample size for the training set
Not applicable. No training set for an algorithm.
9. How the ground truth for the training set was established
Not applicable. No training set for an algorithm.
In summary, the provided document describes a regulatory submission (510(k)) for a physical medical device. It is not an AI/ML device and therefore the questions pertaining to acceptance criteria and study designs relevant to AI/ML algorithms are not applicable to this text. The "study" here is essentially the comparison and justification provided by the manufacturer (Parallax Medical, Inc.) to the FDA for demonstrating substantial equivalence to a predicate device.
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IV. 510(k) Summary
JUL 2 5 2002
This summary of safety and effectiveness is being submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 CFR §807.92.
A. Date Prepared
June 28, 2002
B. General Information
| Manufacturer: | Parallax Medical, Inc.940 Disc DriveScotts Valley, CA 95066-4544 |
|---|---|
| Contact: | Richard M. RuedyDirector, Regulatory and Clinical Affairs(831) 439-0130 phone(831) 439-1725 fax |
C. Device Information
| Trade Name: | Clearview Plus Bone and Vertebral Body Biopsy Needles |
|---|---|
| Common Name: | Bone Biopsy Needle |
| Device Classification: | II |
| Classification Name: | Gastroenterology-Urology Biopsy Instrument |
| Product Code(s): | 78 KNW |
| Classification Regulation: |
21 CFR §876.1075 - Gastroenterology-urology biopsy instrument
D. Predicate Device Identification
The subject device is substantially equivalent to Clearview Bone and Vertebral Body Biopsy Needles (K011206, July 18, 2001).
E. Intended Use
Clearview Plus Bone and Vertebral Body Biopsy Needles are intended for use by a physician performing bone or vertebral body biopsy using a coring (cutting) or aspiration technique.
F. Product Description
The Clearview Bone and Vertebral Body Biopsy Needles consist of a cannula/stylet assembly in 11 and 13 gauge configurations. The needles have a useable length of 4.565 in (11.6 cm).
The modified Clearview Plus Bone and Vertebral Body Biopsy Needles consist of a cannula/stylet assembly and are available in an 11 gauge configuration. The additional components include:
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- . 10cc VacLok syringe
- Luer cap .
- 13.5 gauge inner cannula (useable length 5.355 in, 13.6 cm) .
The needles useable length of 4.565 in (11.6 cm) is the same for the original design and for the modified design. The modified product and the original product are both provided sterile and for single use only.
G. Substantial Equivalence
The subject device is equivalent in intended use, design, and technological characteristics to the Clearview Bone and Vertebral Body Biopsy Needles, K011206.
H. Summary
Based on the information provided in this notification, the subject device is substantially equivalent to the predicate devices in intended use, technological characteristics, and design.
l. Signature of Preparer
The 510(k) summary was prepared and submitted by the following Parallax Medical employee.
Richard M. Ruedy Director, Regulatory and Clinical Affairs
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or clothing.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 5 2002
Parallax Medical, Inc. Richard M. Ruedy Director, Regulatory and Clinical Affairs 940 Disc Drive Scotts Valley, California 95066-4544
Re: K022169
Trade Name: Clearview Plus Bone and Vertebral Body Biopsy Needles Regulation Number: 876.1075 Regulation Name: Gastroenterology/Urology Biopsy Instrument Regulatory Class: II Product Code: KNW Dated: July 2, 2002 Received: July 3, 2002
Dear Mr. Ruedy:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 -- Mr. Richard M. Ruedy
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html
Sincerely yours.
Stypt Aurelius
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Statement of Indications for Use III.
| Indications for Use |
|---|
| --------------------- |
| 510(k) Number (if known): | K022169 |
|---|---|
| Device Name: | Clearview Plus Bone and Vertebral Body Biopsy Needles |
Indications for Use:
Clearview Plus Bone and Vertebral Body Biopsy Needles are intended for use by a physician performing bone or vertebral body biopsy using a coring (cutting) or aspiration technique.
(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 | K022169 | |
|---|---|---|
| Prescription Use (Per 21 CFR 801.109) | OR | Over-The Counter Use (Optional Format 1-2-96) |
§ 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.