Phlebotest 2000 is a system for peripheral vascular diagnostic investigations.
Outflow phethysmography (OP)
Passive Drain and Refill (PDR)
Exercise Venous Plethysmography (EVP)
Triple Test (TTT) Combination of OP, PDR, and EVP
Either Strain Gauges or Air Pressure Cuffs
Prescription device by a physician

Device Description

The PHLEBOTEST 2000 is a system designed for peripheral vascular diagnostic investigations. The center of the system is a specially developed patient chair, which can be positioned according to the investigation performed. The patient can be in a sitting or laying position, with legs positioned in different angels using the movable heel and foot support. Patient elevation between laying and sitting positions can be carried out in various speeds according to investigational requirements. All movements are carried out with low-voltage electrical motors and are directed by a remote hand controller. A pneumatic system consisting of a compressor, pressure tank and valve system is integrated in the system. Different sensors can be attached to the patients for measuring the various examination possibilities. The sensors and pneumatic system are fully integrated and controlled by hardware and software in connection with a PC Windows-based computer. A number of special developed software programs for various diagnostic tests support the system.

AI/ML Overview

This document is a 510(k) summary for the Phlebotest 2000, a plethysmograph system. It primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain detailed information about acceptance criteria, a specific study proving device performance against such criteria, or the methodology of clinical trials typically associated with AI/ML devices. Therefore, a direct answer to your detailed request about acceptance criteria and a study proving performance (especially in the context of AI/ML evaluation) cannot be fully provided from the given text.

However, based on the information provided, here's what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not present in the document. The 510(k) submission focuses on demonstrating substantial equivalence to a legally marketed predicate device (Eureka Varitest (Phlebotest) K882547), rather than setting and meeting specific performance criteria in a new clinical study. The "Technical Characteristics Summary" states: "Osborn Medical Corporation undertook extensive verifications of the software and testing to appropriate standards to verify the Phlebotest's safety and functional outcomes," but it does not specify what those standards were, what the acceptance criteria were, or the quantitative results of those verifications.

2. Sample Size Used for the Test Set and Data Provenance:

This information is not present in the document. No clinical test set or data provenance details are provided.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

This information is not present in the document. The concept of "ground truth" established by experts for a test set is typically relevant for evaluating diagnostic or predictive devices, especially AI/ML ones, which is not the primary focus of this 510(k) submission for a plethysmograph system.

4. Adjudication Method for the Test Set:

This information is not present in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or at least not reported in this document. This type of study is more common for diagnostic imaging AI devices, which is not the nature of the Phlebotest 2000.

6. If a Standalone Study Was Done:

The document mentions "extensive verifications of the software and testing to appropriate standards to verify the Phlebotest's safety and functional outcomes." While this implies some form of standalone testing, the details of a formal "standalone (i.e. algorithm only without human-in-the-loop performance)" study as might be conducted for an AI/ML device are not provided. The device itself is a system with integrated hardware and software, where human interaction is inherent in its intended use (attaching sensors, operating the system).

7. The Type of Ground Truth Used:

This information is not present in the document. Given the device is a plethysmograph for peripheral vascular diagnostic investigations, its performance would likely be evaluated against established physiological measurements or another validated plethysmograph. However, the details of such "ground truth" and its establishment are not in this document.

8. The Sample Size for the Training Set:

This information is not present in the document. The device descriptions do not suggest that it employs machine learning or AI models that would require a "training set" in the conventional sense.

9. How the Ground Truth for the Training Set Was Established:

This information is not present in the document, as there is no mention of a training set for an AI/ML model.

Summary

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4 2002 NOV

Image /page/0/Picture/1 description: The image shows the logo for Osborn Medical. The logo consists of a stylized human figure with arms raised above its head, followed by the text "Osborn Medical" in a serif font. The figure is black, and the text is also black.

osbornmed@osbornmedical.com

Customer Service: 800.535.5865 Fax: 507.932.5044 Telephone: 507.932.5028

100 West Main P.O. Box 324 Utica, MN 55979 USA

022047

510(k) SUMMARY of SAFETY and EFFECTIVENESS

A. General Information

1. Submitter's Name: Osborn Medical Corporation
100 West Main 2. Address: Utica Minnesota 55979
1. Telephone: 507-932-5028
1. Contact Person: Bill Davis
1. Date Prepared: June 18, 2002
1. Registration Number: 2184046

B. Device

Phlebotest 2000 1. Name:
1. Trade Name: Phlebotest 2000
1. Common Name: Plethysmograph
Plethysmograph 4. Classification Name:
1. Product Code: JOM
1. Class: II
1. Regulation Number: 870.2870

C. Identification of Legally Marketed Devices

l. Name: Varitest (Phlebotest) 2. K Number: K882547
w . o s b o r n m e d i c a l . e o ۱۱: | | |

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K022047 22/2

D. Description of the Device

The PHLEBOTEST 2000 is a system designed for peripheral vascular diagnostic investigations.

The center of the system is a specially developed patient chair, which can be positioned according to the investigation performed. The patient can be in a sitting or laying position, with legs positioned in different angels using the movable heel and foot support. Patient elevation between laying and sitting positions can be carried out in various speeds according to investigational requirements.

All movements are carried out with low-voltage electrical motors and are directed by a remote hand controller. A pneumatic system consisting of a compressor, pressure tank and valve system is integrated in the system.

Different sensors can be attached to the patients for measuring the various examination possibilities. The sensors and pneumatic system are fully integrated and controlled by hardware and software in connection with a PC Windows-based computer.

A number of special developed software programs for various diagnostic tests support the system.

E. Intended Use Statement

트 Phlebotest 2000 is a system for peripheral vascular diagnostic investigations.
- 트 Outflow phethysmography (OP)
- 트 Passive Drain and Refill (PDR)
- Exercise Venous Plethysmography (EVP)
- I Triple Test (TTT) Combination of OP, PDR, and EVP
- 프 Either Strain Gauges or Air Pressure Cuffs

F. Technical Characteristics Summary

The Phlebotest 2000 is substantially equivalent to the Eureka Varitest (Phlebotest) cleared on November 3, 1988.

Osborn Medical Corporation undertook extensive verifications of the software and testing to appropriate standards to verify the Phlebotest's safety and functional outcomes.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white and appears to be a scan of a document.

: 发生

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV. 4 2002

Osborn Medical, Inc. c/o Mr. Bill D. Davis President 100 West Main P.O. Box 324 Utica, Minnesota 55979

Re: K022047

Trade Name: Phlebotest 2000 Regulation Number: 21 CFR 870.2780 Regulation Name: Hydraulic, Pneumatic, or Photoelectric Plethysmograph Regulatory Class: Class II (two) Product Code: JOM Dated: October 8, 2002 Received: October 9, 2002

Dear Mr. Davis:

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.

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Page 2 - Mr. Bill D. Davis

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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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) 594-4646. 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 vours.

Bram D. Zuckerman, M.D.
Director

Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number: To be determined 长心乙

Device Name: Phlebotest 2000

Indications for Use:

Phlebotest 2000 is a system for peripheral vascular diagnostic investigations. ●
- Outflow phethysmography (OP) .
- Passive Drain and Refill (PDR) ●
- Exercise Venous Plethysmography (EVP) .
- Triple Test (TTT) Combination of OP, PDR, and EVP ●
- Either Strain Gauges or Air Pressure Cuffs .
- Prescription device by a physician

PLEASE DO NOT WRITE BELOW THIS LINE -Continue on another Page if needed

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X

OVER-THE-COUNTER USE (optional Form 1-2-96)

Division of Cardiovascular & Respiratory Devices
510(k) Number K022047

Regulation Number and Section

§ 870.2780 Hydraulic, pneumatic, or photoelectric plethysmographs.

(a)
Identification. A hydraulic, pneumatic, or photoelectric plethysmograph is a device used to estimate blood flow in a region of the body using hydraulic, pneumatic, or photoelectric measurement techniques.(b)
Classification. Class II (performance standards).