(255 days)
The Quantel Medical POCKET Ultrasonic Pachymeter is intended to be used for the measurement of corneal thickness which is required for some types of corneal surgery.
The POCKET is a small, hand-held ultrasonic Ophthalmic Pachymeter that uses the principles of sonar (pulsed ultrasound) to measure corneal thickness. The device allows the operator to pre-plan a series of measurements on the surface of the cornea, to go automatically from one to the other while making the measurements, and then to present the results of the measurements as thickness over an area of the eye.
The provided document describes the Quantel Medical S.A. "Pocket" Ultrasonic Pachymeter, a device for measuring corneal thickness. The submission focuses on demonstrating substantial equivalence to legally marketed predicate devices rather than providing detailed acceptance criteria or a comprehensive study report for the device's performance.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety standards (IEC 601-1 and 601-1-2) | The POCKET has passed all tests for IEC 601-1 and 601-1-2. |
| Accuracy | Accuracy tests done by an outside laboratory. (Specific values or pass/fail criteria are not provided in this document). |
| Transducer output emissions | Output emissions done by an outside laboratory. (Specific values or pass/fail criteria are not provided). |
| Software validation | Undergone extensive validation testing. (Details of validation testing and results are not provided). |
| Equivalence in safety and efficacy to predicate devices | Concluded to be equivalent in safety and efficacy based on non-clinical tests and the predicate devices' history of "Billed in I OCREF assos and in Europe for several years and has not had reported problems." (No direct comparative clinical study with specific metrics is mentioned). |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "Since the POCKET uses the same technology as existing devices, clinical tests are Billed in I OCREF assos and in Europe for several years and has not had reported problems."
This indicates that new clinical tests with a defined test set were not conducted for the "Pocket" device. Instead, the submission relies on the established performance and safety record of predicate devices already on the market. Therefore, there is no specified sample size for a test set for this device, and no new data provenance is reported.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Since no new clinical tests were performed for the "Pocket" device, no experts were used to establish ground truth for a new test set. The claim of safety and efficacy is based on the performance of predicate devices over several years.
4. Adjudication Method for the Test Set
As no new clinical tests were performed, there was no adjudication method applied to a new test set for the "Pocket" device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study was not conducted. The submission does not present any data on human reader improvement with or without AI assistance, as it is a standalone pachymeter and not an AI-assisted diagnostic tool for human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The device is an ultrasonic pachymeter, which is inherently a standalone measurement device. The performance data focuses on non-clinical tests (IEC standards, accuracy, output emissions, software validation) and equivalence to predicate devices, implying its standalone performance is being asserted. However, a formal "standalone study" with a defined protocol and performance metrics against a gold standard for the "Pocket" device itself (beyond general accuracy tests) is not described in detail.
7. Type of Ground Truth Used
For the non-clinical tests, the ground truth would be established by:
- IEC standards: Compliance with predefined test protocols and specifications for electrical safety and electromagnetic compatibility.
- Accuracy tests: Likely comparison against a known standard or calibrated reference for thickness measurement.
- Transducer output emissions: Measurement against regulatory limits for ultrasound output.
- Software validation: Verification against software requirements and design specifications.
For the equivalence claim, the "ground truth" is implied by the historical performance and lack of reported problems with the predicate devices in Europe and other regions. This is not a direct "ground truth" for the "Pocket" device's clinical measurements but rather an reliance on the established safety and efficacy of similar technology.
8. Sample Size for the Training Set
There is no mention of a training set in the context of an algorithm or machine learning model. This device is a measurement instrument based on established ultrasonic technology, not a learning-based artificial intelligence system.
9. How the Ground Truth for the Training Set Was Established
As there is no training set, this question is not applicable.
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K993674
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Ouantel Medical S.A.. 510(k) Submission "Pocket" Ultrasonic Pachymeter
510(k) Summary
(1) Submitter Information
Name: Quantel Medical S.A.
Address: 89, Boulevard Etienne Clémentel 63100 Clermont-Ferrand FRANCE
Telephone Number: +33 (0) 473-25-62-27
Contact Person: Dr. George Myers (Official Correspondent) Medsys Inc. 377 Route 17 S Hasbrouck Heights, NJ 07604 Telephone 201-727-1703 Fax 201-727-1708
Date Prepared: October 26, 1999
(2) Name of Device
Trade Name: "Pocket" Ultrasonic Pachymeter Common Name: Ultrasonic Pachymeter for Measurement of Corneal thickness Classification name: System, Imaging, Ultrasonic, Ophthalmic, 9801YO
(3) Equivalent legally-marketed devices.
(4) Description
The POCKET is a small, hand-held ultrasonic Ophthalmic Pachymeter that uses the principles of sonar (pulsed ultrasound) to measure corneal thickness. The device allows the operator to pre-plan a series of measurements on the surface of the cornea, to go automatically from one to the other while making the
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K993674
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measurements, and then to present the results of the measurements as thickness over an area of the eye.
- (5) Intended Use
The device is intended to be used for the measurement of corneal thickness by The device is mich is required for some types of corneal surgery.
(6) Performance Data
. (a) Non-clinical tests
The POCKET has passed all tests for IEC 601-1 and 601-1-2. The unit has also had accuracy tests done by an outside laboratory.
Transducers have had output emissions done by an outside laboratory.
The Pocket software has undergone extensive validation testing.
(b) Clinical tests
Since the POCKET uses the same technology as existing devices, clinical tests are Billed in I OCREF assos and in Europe for several years and has not had reported problems.
(c) Conclusions
The Pocket pachymeter is equivalent in safety and efficacy to the legallymarketed predicate devices.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three stripes forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
JUL 1 3 2000
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Quantel Medical S.A. c/o George H. Myers, Sc.D. Official Correspondent Medsys, Inc. 377 Route 17 South Hasbrouck Heights, NJ 07604
K993674 Re : Quantel Pocket Ultrasonic Pachymeter Regulatory Class: II/21 CFR 892.1560 Product Code: 90 IYO Dated: June 16, 2000 Received: June 19, 2000
Dear Dr. Myers:
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 Quantel Packet Ultrasonic Pachymeter, as described in your premarket notification:
Transducer Model Number
P1 (20 MHz A-Scan)
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 Quality System Requlation (QS) 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 requlatory 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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Page 2 - George H. Myers, Sc.D.
This letter will allow you to begin marketing your device as described in your 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 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 Other general information on your responsibilities under the Act may 807.97). be obtained from the Division of Small Manufacturers Assistance at its tollfree 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. Sezom
Daniel G. Schultz, M.D.
Daniel G. Schultz, M.D. Captain, USPHS Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Quantel Medical
Diagnostic Ultrasound Indications for Use Form
Page
510(k) Number (if known):
Device Name: Quantel Medical S.A. ''Pocket'' Pachymeter
Intended Use: The Quantel Medical POCKET Ultrasonic Pachymeter is intended to be Intended Use: The Qualitel Mcdical I OCRET Offically of the some types of corneal surgery.
| CLINICALAPPLICATION | A | B | M | PWD | CWD | COLORDOPPLER | POWER(AMPLITUDE)DOPPLER | COLORVELOCITYIMAGING | COMBINED(SPECIFY) | OTHER(SPECIFY) |
|---|---|---|---|---|---|---|---|---|---|---|
| Ophthalmic | N | |||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intra-operative(specify) | ||||||||||
| Intra-operativeNeurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ | ||||||||||
| (Specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Trans-esophageal | ||||||||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Intra-luminal | ||||||||||
| Peripheral | ||||||||||
| Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-Skeletal | ||||||||||
| Other (Specify)* |
Mode of Operation
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 810.109) | |
|---|---|---|
| ------------------ | --------------- | ---------------------- |
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
| 510(k) Number | K993674 |
|---|---|
| --------------- | --------- |
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§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.