(128 days)
The TonoPach Ultrasonic Tonometer/Pachymeter Model P-201 is a diagnostic instrument that is intended for use in the measurement of both intraocular pressure and corneal thickness. It is intended for use during or following surgery and as a screening, monitoring or diagnostic aid in patients with normal, disease-induced or surgically altered anatomy, or in glaucoma suspects under current therapeutic guidelines.
The TonoPach is a portable, battery operated, handheld ophthalmic instrument which measures both intraocular pressure (IOP) and corneal thickness (CT) simultaneously and at the same locus on the cornea. The device uses the principles of applanation pneumatometery to measure IOP and the principles of reflection pulsed ultrasound pachymetry to measure CT. The system is comprised of the TonoPach electronics, transducer handpiece, protective membranes and optionally, a foot pedal.
The provided 510(k) summary for the RetinaPharma TonoPach Ultrasonic Tonometer/Pachymeter Model P-201 primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a rigorous study report with specific performance metrics against those criteria. However, I can extract the information that is present and highlight what is missing based on your request.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state acceptance criteria in the typical format of sensitivity, specificity, accuracy, or other performance metrics. Instead, it refers to performance specifications being "met or exceeded" and data generally showing "accuracy and reproducibility."
| Measurement | Acceptance Criteria (Implicit/Stated) | Reported Device Performance |
|---|---|---|
| Pachymetry (Corneal Thickness) | Clinical accuracy: +/- 5 µm | Meets or exceeds specifications. (Implied from comparison to predicate devices and general statements on testing) |
| Measurement range: 125 to 1300 um | Device measures within this range. (Comparative table) | |
| Least significant display digit: 1 um | Device displays to this precision. (Comparative table) | |
| Tonometry (Intraocular Pressure - IOP) | Pressure range: 5-80 mm Hg | Device measures within this range. (Comparative table) |
| Pressure traceability: Manometer & Goldmann (Implied as verification) | "TonoPach meets or exceeds specifications." (Based on comparison to Goldmann tonometry) | |
| Reproducibility | "The data exceeds product specifications." (From pig eye study) | |
| Accuracy | "TonoPach meets or exceeds specifications." (From clinical trial, based on scatter and Bland & Altman plots) |
Missing from the table: Specific numerical acceptance criteria for sensitivity, specificity, or overall accuracy values (e.g., "sensitivity > 90%"). The document makes general statements about meeting or exceeding specifications but doesn't quantify those specifications.
2. Sample Size Used for the Test Set and Data Provenance
- Pachymetry Test Set: The document does not explicitly state a separate independent test set for pachymetry for which detailed performance metrics are provided. The "inanimate" and "animal" studies included pachymetry evaluation.
- Inanimate: Polycarbonate wafers of varying thicknesses.
- Animal: Live rabbit eyes.
- Tonometry Test Set:
- Sample Size: "347 eyes" were tested in a clinical trial for comparison to Goldmann tonometry.
- Data Provenance: "Eye clinic volunteers who required tonometery." Location not specified, but likely within the U.S. as it's a U.S. company submitting to FDA. Retrospective or Prospective is not explicitly stated for the clinical trial, but the description "All patients who agreed to volunteer were admitted to the study" suggests a prospective collection of data for the purpose of the study.
- Animal: Three porcine eyes were used for a reproducibility study at each 10 mmHg pressure over a range of 5 to 80 mmHg. (This is for reproducibility, not accuracy against a ground truth). Live rabbit eyes were also used for evaluation.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Pachymetry: The ground truth for inanimate models (polycarbonate wafers) would be the known, precisely measured thickness of the wafers. For animal studies, the ground truth source is not specified (e.g., calibrated caliper, optical pachymetry). No human experts are described as establishing ground truth for pachymetry in the provided text.
- Tonometry: The ground truth for the clinical trial was Goldmann tonometry. Goldmann tonometry is a widely accepted clinical standard for measuring IOP. While this inherently involves a human operator (likely an ophthalmologist or trained technician), the document does not specify the "number of experts" or their "qualifications" involved in performing the Goldmann measurements to establish ground truth for the 347 eyes.
4. Adjudication Method for the Test Set
- The document does not describe any adjudication method for either the pachymetry or tonometry test sets. For the clinical tonometry comparison, it's a direct comparison against Goldmann tonometry, implying the Goldmann reading itself was considered the reference, not an adjudicated value from multiple observers.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC comparative effectiveness study was performed or reported. The TonoPach is a diagnostic instrument that provides a direct measurement (IOP and CT), not an interpretive imaging device for which human readers would typically "improve with AI vs without AI assistance." Its primary use is as a measurement tool, analogous to a thermometer or blood pressure cuff, which is operated by a healthcare professional.
6. Standalone Performance
- Yes, standalone performance was assessed. The entire testing described (inanimate, animal, and human clinical trial) is a "standalone" evaluation of the TonoPach device's ability to measure IOP and CT and its agreement with established methods/standards. There is no human-in-the-loop component where the device's output is modified or interpreted by a human to produce the final result. The device provides its measurement, which a clinician then uses.
7. Type of Ground Truth Used
- Pachymetry:
- Inanimate: Known thickness of polycarbonate wafers.
- Animal: Not explicitly stated, but implies methods to independently measure corneal thickness for comparison.
- Tonometry:
- Inanimate: Water-filled spherical membrane with a manometer (acting as a controlled, known pressure).
- Animal: Not explicitly stated for performance against a "ground truth" for accuracy, more for reproducibility.
- Clinical Trial: Goldmann tonometry was used as the reference standard for comparison.
8. Sample Size for the Training Set
- The document does not provide any information about a "training set" or how the device was developed using machine learning or AI. The product description suggests it operates on known physical principles (applanation pneumatometry for IOP, reflection pulsed ultrasound pachymetry for CT). Devices cleared under the 510(k) pathway, especially from 2004, often did not involve machine learning and thus would not have separate training data sets in the AI sense. The "testing" described is for verification and validation of accuracy and reproducibility.
9. How Ground Truth for the Training Set Was Established
- As no training set is mentioned (likely because the device does not employ machine learning that would necessitate one), this information is not applicable/not provided.
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510(k) SUMMARY
| 1 | Submitter (Contact) Information | |
|---|---|---|
| A | Company Name/Address: | RetinaPharma Technologies, Inc. |
| 944 Morgan Road | ||
| Jenkintown, PA 19046 | ||
| B | Company Phone: | (215) 885-4558 |
| C | Company Fax: | (215) 885-2788 |
| D | Contact Person: | Terry A. Fuller, Ph.D. |
| President | ||
| E | Manufacturing Location: | The Company has not established a manufacturing facility. |
| It will notify the Agency upon its establishment. |
- 2 Device Information
A Device Trade Name: TonoPach™ Ultrasonic Tonometer/Pachymeter Model P-201 (the "TonoPach™")
B Device Classification:
The TonoPach is a combination of two devices, a pneumatometer and a pachymeter, which have already been determined to be substantially equivalent to legally marketed predicate devices with regard to safety, effectiveness and intended use. The device classifications are presented in the following table.
| Pneumatometer | Pachymeter | |
|---|---|---|
| Common Name: | Tonometer for MeasuringIntraocular Pressure | Ultrasonic Pachymeterfor Measurement ofCorneal Thickness |
| Classification Name: | Tonometer, AC Powered | Ultrasonic Pulsed EchoImaging System |
| Product Code: | HKX | 90-IYO |
| Regulatory Class & Tier: | II | II |
| Regulatory Number: | 21 CFR 866.1930 | 21 CFR 892.1560 |
| Classification & ReviewAdvisory Committees | Ophthalmic | Radiology |
3 Substantial Equivalence
The RetinaPharma TonoPach Ultrasonic Tonometer/Pachymeter is judged to be substantially equivalent in safety, effectiveness and intended use to the following legally marketed devices:
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| Predicate Device | Manufacturer | 510(k) | Date Cleared |
|---|---|---|---|
| TonoPen ophthalmictonometer | Oculab, Inc. | K 852774 | August 20, 1985 |
| Pocket UltrasonicPachymeter | Quantel Medical, Inc. | K993674 | July 13, 2000 |
| Echoscan Model US-1800 | Nidek, Inc. | K020876 | May 3, 2002 |
I ist of predicate devices
Device Description. ব
The TonoPach is a portable, battery operated, handheld ophthalmic instrument which measures both intraocular pressure (IOP) and corneal thickness (CT) simultaneously and at the same locus on the cornea. The device uses the principles of applanation pneumatometery to measure IOP and the principles of reflection pulsed ultrasound pachymetry to measure CT. The system is comprised of the TonoPach electronics, transducer handpiece, protective membranes and optionally, a foot pedal.
ട Intended Use
The TonoPach Ultrasonic Tonometer/Pachymeter Model P-201 is a diagnostic instrument that is intended for use in the measurement of both intraocular pressure and corneal thickness. It is intended for use during or following surgery and as a screening, monitoring or diagnostic aid in patients with normal, disease-induced or surgically altered anatomy, or in glaucoma suspects under current therapeutic guidelines.
6 Technological Equivalence
Table 6.1 provides a list of predicate devices and the "k" number. In Tables 6.2, 6.3 and 6.4 the TonoPach Pachymeter portion and the Ultrasonic Tonometer are compared, respectively, to predicate devices to show the equivalence. Description statements were relied on to ascertain the intended use and technological features of legally marketed devices, and the substantial equivalence to the TonoPach to such legally marketed devices. The comparison of the intended use and technological features of this device to other legally marketed devices indicates that this device is substantially equivalent to legally marketed predicate devices with regard to safety, effectiveness and intended use. Note: areas of difference between the two devices are indicated in the tables. RetinaPharma believes that these differences are minor and should not raise any concerns regarding the overall safety and efficacy of the TonoPach.
| Table 6.1: List of predicate devices | |||
|---|---|---|---|
| Predicate Device | Manufacturer | 510(k) | Date Cleared |
| TonometerTonoPen ophthalmic tonometer | Oculab, Inc. | K 852774 | August 20, 1985 |
| PachymeterPocket Ultrasonic PachymeterEchoscan Model US-1800 | Quantel Medical, Inc.Nidek, Inc. | K993674K020876 | July 13, 2000May 3, 2002 |
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| Table 6.2: Comparison of Tonometer Characteristics | ||
|---|---|---|
| TonoPen vs. TonoPach P 201 | ||
| Predicate DeviceMentor TonoPen 3 | RetinaPharmaTonoPach P 201 | |
| Measurement | IOP | IOP |
| Pressure measurement device | Micro strain gauge | Micro strain gauge |
| Measurement technique | Applanation | Applanation |
| Pressure range | 5-80 mm Hg | 5-80 mm Hg |
| Pressure contact area* | 1.5 mm | 1.8 mm |
| Measurement frequency | 500 reading per second | 500 readings per second |
| Display/measure | LCD / 2 digit reading | LCD / 2 digit reading |
| Statistical storage | Yes | Yes |
| Pressure traceability | Manometer & Goldmann | Manometer & Goldmann |
| Usage | Handheld | Handheld or Slitlamp mounted |
| Power supply | Battery | Battery |
| System configuration* | Single unit; transducer andsystem electronics combined | Tethered unit; transducer istethered from the systemelectronics |
| Versatility | Can be used with the patient inany position, making it suitablefor use in the office, bedside or inremote locations. Suitable for usein cases of their regular or Hgcorneal astigmatism. | Can be used with the patient inany position, making it suitablefor use in the office, bedside or inremote locations. Suitable for usin cases of their regular or Hgcorneal astigmatism. |
| *Indicates differences between the predicate device and TonoPach |
| Table 6.3: Comparison of Pachymeter Characteristics"Pocket" Ultrasonic Pachymeter and Echoscan US-1800 vs. TonoPach P 201 | |||
|---|---|---|---|
| Predicate Device"Pocket" | Predicate DeviceEchoscan US-1800 | RetinaPharmaTonoPach P 201 | |
| Measurement | Corneal thickness | Corneal thickness | Corneal thickness |
| Measurement system | Ultrasonic pulsereflection | Ultrasonic pulsereflection | Ultrasonic pulsereflection |
| Probe type | Solid,Angled | Solid,Straight, Angled | SolidStraight, Angled |
| Measurement range* | 100 to 1300 um | 200 to 1300 um | 125 to 1300 um |
| Clinical accuracy | +/- 5 um | +/- 5 um | +/- 5 um |
| Least significant displaydigit | 1 um | 1 um | 1 um |
| Default velocity* | 1620 m/sec | 1640 m/sec,changeable | 1640 m/sec |
| Exam Mode(s) | Single point, 1 map | Single point, 3 maps | Single point, 1 map |
| Data Output | LCD, Print | LCD, Print | LCD, Print |
| Power requirements | Battery | 120 VAC, 60 Hz | Battery |
| Weight | 0.46 kg | 6 kg | 0.75 kg |
| *Pachymeter mode. Indicates difference between the predicate device and the TonoPach |
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7 TonoPach Testing
Substantial testing has been performed using the TonoPach. It includes inanimate, animal and human evaluation.
- A Inanimate: Models for both tonometry and pachymetry have been used.
- l ) The tonometry model consists of a water-filled spherical membrane attached to a manometer. When the TonoPach handpiece tip touches the sphere, it mimics intraocular pressure.
-
- The pachymetry model consists of polycarbonate wafers of varying thicknesses. When the TonoPach handpiece tip touches a wet wafer, it is suitable to mimic the cornea for thickness measurement purposes.
- B Animal: Live rabbit eyes and freshly enucleated porcine eyes were used for several studies.
- l) Rabbit eyes were used to test the tonometer and pachymeter portions of the TonoPach. They were used to evaluate the TonoPach's performance on a live eye. Also, they were used to assist in evaluation of the System's numerical accuracy and reproducibility.
-
- Pig eyes were used predominately to verify and validate tonometer accuracy and reproducibility. One study was used to demonstrate repeatability. Three porcine eyes were studied at each 10 mmHg pressure over a pressure range of 5 to 80 mmHg with 10 independent measurements per pressure. The data exceeds product specifications.
- C Clinical Crial: The TonoPach was evaluated on eye clinic volunteers who required tonometery. All patients who agreed to volunteer were admitted to the study.
-
- Tonometry testing was the predominated the data collected. 347 eyes were tested for comparison to Goldmann tonometery. Scatter and Bland & Altman plots as well as mean, standard deviation and variance around the mean reveal that the TonoPach meets or exceeds specifications.
-
8 Statement of Confidentiality
Information contained in this letter and its attachments is considered confidential, proprietary information and a trade secret until RetinaPharma Technologies, Inc. distributes such information publicly. The release of information contained herein is to be governed by applicable provisions of the Food, Drug and Cosmetic Act, the Freedom of Information Act and pertinent FDA regulations in 21 CFR Part 20.
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 0 2004
RetinaPharma Technologies, Inc. % Terry Fuller, Ph.D. 944 Morgan Road Jenkintown, PA 19046
Re: K042099
Trade/Device Name: TonoPach Ultrasonic Tonometer/Pachymeter Model P-201 Regulation Number: 21 CFR 886.1930 Regulation Name: Tonometer and accessories Regulatory Class: Class II Product Code: HKX Dated: July 30, 2004 Received: August 4, 2004
Dear Dr. Fuller:
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.
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 - Terry Fuller
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 (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
A halyl Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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3) Diagnostic Ultrasound Indications for Use Form
Page 1 of 1
510(k) Number (if known):
Device name: RetinaPharma Model P 201, TonoPachTM System
Intended Use: The TonoPach Ultrasonic TonometerPachymeter Model P-201 is a diagnostic instrument that is intended for use in the measurement of both intraccular pressure and corneal thickness. It is intended for use during or following surgery and as a screening, monitoring or diagnostic aid in patients with normal, disease-induced or surgically altered anatomy, or in glaucoma suspects under current therapeutic guidelines.
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(specify) | Other(specify) | |
| Ophthalmic | N | |||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| IntraoperativeNeurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | ||||||||||
| Musculo-skeletalSuperficial | ||||||||||
| 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) |
|---|---|
| ------------------ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Clay R. Butterman | |
|---|---|
| (Division Sign-Off) | |
| Division of Ophthalmic Ear, | |
| Nose and Throat Devises |
510(k) TonoPach Indications for Use modified 041210.doc
From 510(k) 040729_Cover D.doc
| 510(k) Number | K042099 |
|---|---|
| --------------- | --------- |
§ 886.1930 Tonometer and accessories.
(a)
Identification. A tonometer and accessories is a manual device intended to measure intraocular pressure by applying a known force on the globe of the eye and measuring the amount of indentation produced (Schiotz type) or to measure intraocular tension by applanation (applying a small flat disk to the cornea). Accessories for the device may include a tonometer calibrator or a tonograph recording system. The device is intended for use in the diagnosis of glaucoma.(b)
Classification. Class II.