(66 days)
The Prager Shell® is a plastic device intended to provide a water path between an ultrasound transducer and the eye for A-scan biometry of the eye.
The shell is a cylinder with an open top and open bottom,. The open bottom end is contoured at the rim to conform to the curvature of the eye. The ultrasonic transducer is placed in the Prager Shell® from above. Once placed on the eye the shell is filled with balanced salt solution (BSS) and the probe distal end is immersed in the BSS. It is not sold sterile and is reusable. Tubing kits are available to connect the shell to the BSS source. These kits are distributed by ESI but not manufactured by it.
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Table of Acceptance Criteria and Reported Device Performance:
Feature/Criterion Acceptance Criteria Reported Device Performance Intended Use To provide a water path between an ultrasound transducer and the eye for A-scan biometry. The device description and intended use clearly state: "The Prager Shell® is a plastic device intended to provide a water path between an ultrasound transducer and the eye. It is intended for A-scan biometry of the eye." This aligns with the stated predicate device (Water Bath for Sonometrics Coleman A-B scan system), which also provides a water path for eye ultrasound. Technological Characteristics Made of biologically-compatible rigid plastic, specific models for different transducers, mechanisms to lock onto transducers. The device is described as "made of a biologically-compatible rigid plastic." It is also stated that "Each model fits the transducers of specific ultrasound manufacturers" and that "They are fitted with mechanisms so that they may be locked in place on the transducers." However, explicit acceptance criteria for these characteristics (e.g., specific biocompatibility test results, or detailed fitting specifications) are not provided in the document. The statement implies compliance but doesn't detail the criteria. Safety/Biocompatibility Biocompatibility tests should be done, and the device should be equivalent in safety to the predicate device. "Biocompatibility tests have been done." The document concludes that "The Prager Shell is equivalent in safety and efficacy to the legally marketed predicate device." No specific test results or detailed criteria for biocompatibility are provided within this summary, only that the tests were conducted and the device was deemed equivalent in safety. Clinical Performance/Efficacy Equivalent in efficacy to the legally marketed predicate device for A-scan biometry. The document explicitly states "Clinical tests: Not required" and concludes "The Prager Shell is equivalent in safety and efficacy to the legally marketed predicate device." The basis for this equivalence in efficacy is presumed to be the similarity in intended use and technological characteristics to the predicate (a water bath for sonometry), rather than direct clinical efficacy testing of the new device itself. No specific efficacy metrics or performance results are provided from direct testing of the Prager Shell. Sterility Not sold sterile. The device "is not sold sterile and is reusable." This is a characteristic description rather than a performance acceptance criterion, but it is explicitly stated. -
Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not applicable. The document explicitly states "Clinical tests: Not required" and "Not required" under the performance data section. The device's equivalence was established through non-clinical biocompatibility tests and a comparison of technological characteristics and intended use to a preamendment predicate device, rather than through a clinical test set.
- Data Provenance: Not applicable, as no clinical test set was used for this 510(k) submission.
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Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable, as no clinical test set was used for this 510(k) submission.
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Adjudication Method for the Test Set:
- Not applicable, as no clinical test set was used for this 510(k) submission.
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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 passive accessory (a rigid water path for an ultrasonic transducer) and does not involve AI or human reader interpretation. No MRMC study was conducted or is relevant for this type of device.
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If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device accessory, not an algorithm or software. No standalone algorithm performance evaluation was done.
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The Type of Ground Truth Used:
- Not applicable for performance evaluation based on a test set. The "ground truth" for the 510(k) submission was established by demonstrating substantial equivalence to a legally marketed predicate device (Water Bath for Sonometrics Coleman A-B scan system) based on:
- Identical intended use.
- Similar technological characteristics (biologically-compatible rigid plastic, forms a water path).
- Demonstrated biocompatibility through non-clinical testing.
- Therefore, the ground truth for this submission relies on regulatory comparison and non-clinical testing rather than clinical ground truth like pathology or outcomes data from a test set.
- Not applicable for performance evaluation based on a test set. The "ground truth" for the 510(k) submission was established by demonstrating substantial equivalence to a legally marketed predicate device (Water Bath for Sonometrics Coleman A-B scan system) based on:
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The Sample Size for the Training Set:
- Not applicable, as this is a physical device and not an AI/ML algorithm requiring a training set.
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How the Ground Truth for the Training Set was Established:
- Not applicable, as this is a physical device and not an AI/ML algorithm requiring a training set.
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ESI. Inc. Prager Shell
Page 5-1
10082893
DEC 0 5 2008
ESI Inc. 510(k) Submission Prager Shell®
510(k) Summary September 3, 2008
(1) Submitter Information
Name: ESI, Inc.
Address: 2915 Everest Ln N.
Plymouth, MN 55447
Telephone Number: 763-473-2533
Contact Person: Dr. George Myers
Medsys Inc.
377 Rt. 17 S
Hasbrouck Heights, NJ 07604
201-727-1703
Date Prepared: September 3, 2008
(2) Name of Device:
Trade Name: Prager Shell
Common Name: Rigid Water Path for Ultrasonic Transducers
Classification Name: Scleral Shell (Accessory to ultrasound system).
(3) Equivalent legally-marketed devices:
Preamendment device Water Bath for Sonometrics Coleman A-B scan system.
(4) Description
The shell is a cylinder with an open top and open bottom,. The open bottom end is contoured at the rim to conform to the curvature of the eye. The ultrasonic transducer is placed in the Prager
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Shell® from above. Once placed on the eye the shell is filled with balanced salt solution (BSS) and the probe distal end is immersed in the BSS. It is not sold sterile and is reusable. Tubing kits are available to connect the shell to the BSS source. These kits are distributed by ESI but not manufactured by it.
(5) Intended Use
The Prager Shell® is a plastic device intended to provide a water path between an ultrasound transducer and the eye. It is intended for A-scan biometry of the eye.
(6) Technological Characteristics
The Prager Shell is made of a biologically-compatible rigid plastic. Each model fits the transducers of specific ultrasound manufacturers. They are fitted with mechanisms so that they may be locked in place on the transducers
(7) Performance data
(a) Non-clinical tests
Biocompatibility tests have been done.
(b) Clinical tests
Not required
(8) Conclusions
The Prager Shell is equivalent in safety and efficacy to the legally marketed predicate device.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is depicted in black, and the text is also in black. The logo is simple and recognizable, and it is often used on official documents and websites related to the U.S. Department of Health & Human Services.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 0 5 2008
ESI, Inc. % Mr. George Myers President Medsys, Inc. 377 Route 17 S HASBROUCK HEIGHTS NJ 07604
Re: K082893
Trade/Device Name: Prager Shell Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: ITX Dated: September25, 2008 Received: September 30, 2008
Dear Mr. Myers:
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
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.
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 one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 yours.
Arputh Whang
Joyce M. Whang, Ph.D. Acting Director. Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): KOB2093
Device Name: Prager Shell
Indications For Use:
The Prager Shell® is a plastic device intended to provide a water path between an ultrasound transducer and the eye for A-scan biometry of the eye.
Prescription Use X AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Heilus Reimer
Sign-Off) (Division (Division Sign-Oil)
Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.