(15 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Peripheral Vascular (CWD)
The Nicolet VersaLab is a DC rechargeable battery / DC powered device. The Nicolet VersaLab employs fixed [not adjustable] CW Doppler power levels that are pre-set at a limit below the maximum allowable of 720mw/cm²; therefore, the ALARA condition is always met. There are hardware levels controlling the power as well as redundant software controls.
The provided text does not describe specific acceptance criteria and a study proving the device meets those criteria in the typical sense of a clinical performance study for an AI/ML medical device. Instead, the document is a 510(k) clearance letter from the FDA for the Nicolet VersaLab, a diagnostic ultrasound system.
The "acceptance criteria" here are related to regulatory compliance and safety limits, particularly concerning ultrasound power levels, rather than performance metrics like sensitivity or specificity for a diagnostic output. The "study" mentioned is the manufacturer's assurance that the device adheres to these safety limits and substantially equivalent to predicate devices.
Here's the breakdown of what can be extracted from the provided text, framed against your requested categories, acknowledging that much of the information you've asked for (e.g., sample sizes for test/training sets, expert qualifications, MRMC studies) is not applicable or present in this type of regulatory document for an ultrasound device without AI/ML components.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Criterion | Reported Device Performance |
|---|---|---|
| Instrument Safety (Acoustic Output) | Ultrasound signals emitted at power levels below FDA recommended maximum exposure limits. | - Reported Performance: Fixed (not adjustable) CW Doppler power levels are pre-set at a limit below the maximum allowable of 720 mW/cm². - Evidence: Hardware and redundant software controls are in place to ensure power levels are always met, adhering to the ALARA (As Low As Reasonably Achievable) principle. - Additional Requirement: Post-clearance special report required for acoustic output measurements based on production line devices (as per Appendix G of FDA guidance). This report is a condition for the substantial equivalence. |
| Clinical Classification & Intended Use | Regulatory Class II / 21 CFR 892.1540 (Diagnostic ultrasonic transducer), 21 CFR 870.2880 (Ultrasound imaging system). | - Reported Performance: The device is deemed substantially equivalent for the indications for use stated in the enclosure (primarily Peripheral Vascular, Continuous Wave Doppler). - Evidence: Formal FDA 510(k) clearance (K010521) for the Nicolet VersaLab with 4 MHz (CWD) and 8 MHz (CWD) transducers. |
| Manufacturing & Quality System Compliance | Compliance with Good Manufacturing Practice (GMP) / Quality System Regulation (QSR) for Medical Devices (21 CFR Part 820). | - Reported Performance: Substantial equivalence determination assumes compliance with GMP. - Evidence: FDA states they will verify such assumptions through periodic QS inspections. |
| Labeling Requirements | Adherence to specific labeling regulations (21 CFR Part 801 and 809.10). | - Reported Performance: Implicitly expected for marketing; no direct performance metric here. - Evidence: FDA advises contacting the Office of Compliance for specific advice on labeling regulations. |
2. Sample Size for the Test Set and Data Provenance
This document specifies a medical device (ultrasound system), not an AI/ML algorithm that processes data. Therefore, the concept of a "test set" with a sample size for evaluating an algorithm's performance against ground truth is not applicable in this 510(k) submission.
The "data" referred to in this context would be engineering data confirming acoustic output, electrical safety, biocompatibility (if applicable), and comparison to predicate devices, rather than a clinical dataset for diagnostic performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The "ground truth" here is primarily regulatory compliance with safety standards and substantial equivalence to existing devices, which is evaluated by the FDA based on the manufacturer's submissions and internal expertise.
4. Adjudication Method for the Test Set
Not applicable. There is no "test set" in the context of diagnostic performance requiring adjudication by experts.
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. The Nicolet VersaLab is a diagnostic ultrasound device from 2001, not an AI-powered diagnostic system. No AI assistance or MRMC study is mentioned.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm but a physical medical device.
7. The Type of Ground Truth Used
The "ground truth" for this device's acceptance is based on:
- Regulatory Standards: Compliance with FDA regulations (e.g., 21 CFR parts related to medical devices, GMP).
- Engineering Specifications: Acoustic output measurements meeting established safety limits (e.g., 720 mW/cm²).
- Substantial Equivalence: Comparison to legally marketed predicate devices, demonstrating that the new device is as safe and effective as a device already on the market.
- Safety Data: General understanding of ultrasound safety based on organizations like the American Institute of Ultrasound in Medicine ("No confirmed biological effects...").
8. The Sample Size for the Training Set
Not applicable. This is a conventional medical device, not an AI/ML model that requires training data.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As above, no training set or AI/ML model is involved.
In summary: The provided document is a regulatory clearance for a diagnostic ultrasound device, focusing on its safety (particularly acoustic output) and substantial equivalence to previously cleared devices. It does not describe a clinical performance study involving diagnostic accuracy metrics or AI/ML algorithm evaluation, which would typically involve the types of acceptance criteria and study details you've outlined in your request.
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SUMMARY OF SAFETY and EFFECTIVENESS
Instrument Safety:
- Ultrasound signals are emitted at power levels below FDA recommended maximum exposure limits of 720 mW / cm2-
- The Nicolet VersaLab is labeled for use by or on order of a physician.
- The Nicolet VersaLab is a DC rechargeable battery / DC powered device.
Good Clinical Practice dictates that ultrasound equipment, including the Nicolet VersaLab, should be operated at power levels As Low As Reasonably Achievable [ALARA]. This means that the operator uses Doppler power levels no higher that necessary to obtain blood-flow information that is adequate to make clinical judgements. The Nicolet VersaLab employs fixed [not adjustable] CW Doppler power levels that are pre-set at a limit below the maximum allowable of 720mw/cm²; therefore, the ALARA condition is always met. There are hardware levels controlling the power as well as redundant software controls.
Ultrasound Safety:
The American Institute of Ultrasound in Medicine has issued the following statement concerning the safety of ultrasound:
" No confirmed biological effects on patients or instrument operators caused by exposure at intensities typical of present diagnostic ultrasound instruments have been reported. Although the possibility exists that such biological effects may be identified in the future, current data indicate that the benefits to patients of the prudent use of diagnostic ultrasound outweighs the risks, if any, that may be present".
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
MAR - 9 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. David W. Wagner Director, Quality Assurance and Regulatory Affairs Nicolet Vascular, Inc. 6355 Joyce Drive GOLDEN CO 80403
Re: K010521
Trade Name: Nicolet VersaLab Regulatory Class: II/21 CFR 892.1540/21 CFR 870.2880 Product Code: 90 JAF/90 JOP Dated: February 15, 2001 Received: February 22, 2001
Dear Mr. Wagner:
We have reviewed your Section 510(k) 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 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). 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.
This determination of substantial equivalence applies to the following transducers intended for use with the Nicolet VersaLab, as described in your premarket notification:
Transducer Model Numbers:
4 MHz (CWD) 8 MHz (CWD)
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice requirement, as set forth in the Ouality System Regulation (OS) for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic QS inspections, the FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification does not affect any obligation you may have under sections 531 and 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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This determination of substantial equivalence is granted on the condition that prior to shipping the first I mo determination it a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing (Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbrained they not appris to and phould reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:
Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850
This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of sybstantial 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 market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809 10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4591. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212.
Sincerely yours,
Daniel C. Lyzman
David A. Segerson Acting Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
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Diagnostic Ultrasound Indications for Use Form
Fill out one form for each ultrasound system and each transducer.
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body all follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (specify) | Other (specify) |
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | N | |||||||||
| Laparoscopic | ||||||||||
| Musculo-skelatal Conventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other (specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: (N) SYSTEM UTILIZES IEA 4 MHZ AND 8MHZ CW DIRECTIONAL PROBES
(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 Reproductive, Abdominal, ENT, and Radiological Devices | |
| 510(k) Number | K010521 |
Prescription Use (Per 21 CFR 801.109)
F-3
Prescription Use
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ABARAR 1100% 1-50 INVEDUCEK BMHZ
Fill Out one form (2) and 100 analysis of the human body age follows:
Intended Use: Diagnostic ultrasound imaging of fluid flow analysis of
| Clinical Application | Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (specify) | Other (specify) | |||
| Ophthalmic | ||||||||||||
| Fetal | ||||||||||||
| Abdominal | ||||||||||||
| Intraoperative (specify) | ||||||||||||
| Intraoperative Neurological | ||||||||||||
| Pediatric | ||||||||||||
| Small Organ (specify) | ||||||||||||
| Neonatal Cephalic | ||||||||||||
| Adult Cephalic | ||||||||||||
| Cardiac | ||||||||||||
| Transesophageal | ||||||||||||
| Transrectal | ||||||||||||
| Transvaginal | ||||||||||||
| Transurethral | ||||||||||||
| Intravascular | ||||||||||||
| Peripheral Vascular | N | |||||||||||
| Laparoscopic | ||||||||||||
| Musculo-skeletal Conventional | ||||||||||||
| Musculo-skeletal Superficial | ||||||||||||
| Other (specify) N= new indication; P= previously cleared by FDA; E= added under Appendix E |
Additional Comments:
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use (Per 21 CFR 801.109) | ✓ |
|---|---|
| --------------------------------------- | ---------- |
F-3
(Division Sign-Off
Division of Reproductive
and Radiological D
510(k) Number K010561
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Prescription Use
Diagnostic Ultrasound Indications for Use Form
Fill out one form for each ultrasound system and each transducer.
liter and the our in our of the enalysis of the human body as the human body as tollows:
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (specify) | Other (specify) | |
| Ophthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative (specify) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ (specify) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | N | ||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal Conventional | |||||||||||
| Musculo-skeletal Superficial | |||||||||||
| Other (specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
(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 Reproductive, Abdominal, ENT, and Radiological Devices
Prescription Use (Per 21 CFR 801.109)
510(k) Number K01031
§ 892.1540 Nonfetal ultrasonic monitor.
(a)
Identification. A nonfetal ultrasonic monitor is a device that projects a continuous high-frequency sound wave into body tissue other than a fetus to determine frequency changes (doppler shift) in the reflected wave and is intended for use in the investigation of nonfetal blood flow and other nonfetal body tissues in motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.