(74 days)
The Sensor Medical Technology Family of Disposable Lenses are a family of diagnostic and therapeutic contact lenses used in the examination of the eye fundus, retina and iridocorneal and vitreous bodies and for the laser therapy of intraocular abnormalities.
The Sensor Medical Technology Family of Disposable Lenses is a family of diagnostic and therapeutic contact lenses use for eve examination and therapy of intraocular abnormalities. The Family consists of 14 lenses - 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Mirror Lens, 3 Mirror Lens, Iridotomy Lens, Capsulotomy Lens, Retina 90 Lens, Retina 165 Lens, Retina 180 Lens, Indirect Lenses: 90 D, 78 D, 60 D, 28 D and 20 D.
The Family of Ophthalmic Lenses is designed around the classic Goldmann contact lens. Each model lens is of similar design, but provide different optical elements to provide excellent visualization of the ocular anatomical areas for the particular intended use. When used in conjunction with a slit lamp, the ophthalmic lenses provide a binocular and stereoscopic view of the specific optical region of the eye.
The lenses are provided sterile for single use.
The provided documentation describes a 510(k) premarket notification for the "Sensor Medical Technology LLC Family of Disposable Lenses." This submission primarily focuses on establishing substantial equivalence to a predicate device (Sensor Family of Ophthalmic Lenses, K102371) that was previously 510(k) exempt. The main difference between the new device and the predicate is that the new lenses are provided sterile for single use, whereas the predicate devices were reusable.
Therefore, the performance data presented is focused on demonstrating that the disposable, sterile versions are as safe and effective as the reusable predicate, particularly regarding sterility and shelf life. This is not a study to demonstrate AI/algorithm performance in the typical sense of a diagnostic or predictive device with metrics like sensitivity, specificity, or AUC. Instead, it's a demonstration of product safety and efficacy through engineering and biological testing.
Here's an analysis based on the provided text, highlighting the information (or lack thereof) for each requested point:
Acceptance Criteria and Study for Sensor Medical Technology LLC Family of Disposable Lenses
This submission is for a family of disposable ophthalmic lenses, not an AI or algorithm-based device. The "acceptance criteria" and "device performance" are therefore related to the physical and biological characteristics of the lenses, particularly regarding sterility and shelf life, rather than diagnostic accuracy or clinical effectiveness in the AI context.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Sterilization Requirements | Met the sterilization requirements specified in the sterilization validation protocol. |
| Shelf Life | Confirmed a 24-month shelf life. |
| Substantial Equivalence | Determined substantially equivalent to the predicate device (K102371). |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not specify the sample size for the sterility validation or shelf-life testing. These tests are typically performed on a statistically relevant number of product units from manufacturing lots, but the exact numbers are not reported in this summary. The provenance of the data (country of origin, retrospective/prospective) is also not mentioned, as these are technical validation studies performed by the manufacturer or contracted labs.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This is not applicable. The "ground truth" for sterility is determined by microbiological testing and for shelf life by accelerated or real-time aging studies and subsequent performance testing, not by expert human interpretation in a clinical context.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert interpretations (e.g., reading medical images). Here, the testing involves laboratory procedures for sterility and product stability, where "adjudication" in the human-reader sense does not apply.
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
No. This is not an AI-assisted device. An MRMC study was not performed. The device is a physical ophthalmic lens.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance validation is:
- Sterility Validation: Microbiological test results (e.g., sterility test, bioburden, endotoxin testing) according to recognized standards (e.g., ISO 11135 or ISO 11137 for sterilization, ISO 11737 for bioburden).
- Shelf Life Testing: Physical and functional integrity of the device and its packaging over time, confirmed by various tests (e.g., visual inspection, package integrity, functional performance, and sterility at different time points) after accelerated or real-time aging.
8. The sample size for the training set
This is not applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
This is not applicable as there is no training set.
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510(k) SUMMARY
APR 2 9 2014
Sensor Medical Technology LLC Family of Disposable Lenses
510(k) Owner
Sensor Medical Technology LLC 23175 224th Place SE Maple Valley, WA 98038 (425) 358-7381 Phone: Contact Person: Louise Culham, Ph.D.
Submission Correspondent
Maureen O'Connell O'Connell Regulatory Consultants, Inc. 5 Timber Lane North Reading, MA 01864 Phone: (978) 207-1245 Facsimile: (978) 824-2541
Date Prepared: February 11, 2014
Trade Name of Device
Sensor Medical Technology Family of Disposable Lenses
Common or Usual Name
Gonioscopic Prisms and Diagnostic Condensing Lens
Classification Name and Regulation
Gonioscopic Prisms 21 CFR 886.1660, HKS Ophthalmic Panel
Diagnostic Condensing Lens 21 CFR 886.1380, HJL Ophthalmic Panel
Predicate Devices
Sensor Family of Ophthalmic Lenses (K102371)
Device Description
The Sensor Medical Technology Family of Disposable Lenses is a family of diagnostic and therapeutic contact lenses use for eve examination and therapy of intraocular abnormalities. The Family consists of 14 lenses
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- 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Mirror Lens, 3 Mirror Lens, Iridotomy Lens, Capsulotomy Lens, Retina 90 Lens, Retina 165 Lens, Retina 180 Lens, Indirect Lenses: 90 D, 78 D, 60 D, 28 D and 20 D.
The Family of Ophthalmic Lenses is designed around the classic Goldmann contact lens. Each model lens is of similar design, but provide different optical elements to provide excellent visualization of the ocular anatomical areas for the particular intended use. When used in conjunction with a slit lamp, the ophthalmic lenses provide a binocular and stereoscopic view of the specific optical region of the eye.
The lenses are provided sterile for single use.
Intended Use / Indications for Use
The Family of Disposable Lenses are a family of diagnostic and therapeutic contact lenses used in the examination of the eye fundus, retina and iridocorneal and vitreous bodies and for the laser therapy of intraocular abnormalities.
Substantial Equivalence
Sensor Medical Technology LLC believes that the Family of Disposable Lenses described in this notification and for use under the conditions of proposed labeling is substantially equivalent to the Sensor LLC Family of Ophthalmic Lenses found to be 510(k) Exempt in K102371. The Family of Disposable Lenses has the same indications for use and similar intended use, similar principles of operation, and similar technological characteristics as the prior version of this product that was found to be 510(k) Exempt. The major difference between the prior version of the product and the version presented in this 510(k) is that the Family of Ophthalmic Lenses described in K102371 were reusable while the lenses described here are provided sterile for single use. Sterility and shelf life testing is provided to demonstrate that the product is as safe and effective as the predicate device and is therefore, substantially equivalent.
Performance Data
Sterilization validation testing was performed which showed that the Family of Disposable Lenses met the sterilization requirements specified in the sterilization validation protocol. Shelf life testing was performed which confirmed a 24 month shelf life.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
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April 29. 2014
Food and Drug Administration 118903 New Hampshire Avenue Document Control Center . WObliat 2009 Silver Spring, MID 20993-0002
Sensor Medical Technology, LLC % Ms. Maureen O`Connell Regulatory Consultant O'Connell Regulatory Consultants, Inc. 5 Timber Lanc North Reading. MA 01864
Re: K140368
Trade/Device Name: Sensor Medical Technology LLC Family of Disposable Lenses Regulation Number: 21 CFR 886,1660 Regulation Name: Gonioscopic Prisms Regulatory Class: Class I Product Code: HKS Dated: March 4. 2014 Received: March 5, 2014
Dear Ms. O'Connell.
We have reviewed vour 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. Iisting of devices. good manufacturing practice. labeling, and prohibitions against misbranding and adulteration. Please note: CDRI does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class 111 (PMA), it may be subject to 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 FIDA'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.
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Page 2 - Ms. Maureen O'Connell
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.lda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Deborah L. Falls -S
for Malvina B. Eydelman, 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K140368
Device Name Sensor Medical Technology Family of Disposable Lenses
Indications for Use (Describe)
The Sensor Medical Technology Family of Disposable Lenses are a family of diagnostic and therapeutic contact lenses I he school weather Formores) : annovely, retina and irido-comeal and vitreous bodies and for the laser therapy of intraocular abnormalities.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
Please do not write below this line – continue on a separate page if needed.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Leonid Livshitz -S 2014.04.25 14:21:08 -04'00'
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§ 886.1660 Gonioscopic prism.
(a)
Identification. A gonioscopic prism is a device that is a prism intended to be placed on the eye to study the anterior chamber. The device may have angled mirrors to facilitate visualization of anatomical features.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9.