(74 days)
Not Found
No
The description focuses on the physical design and optical properties of contact lenses for eye examination and therapy, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The "Intended Use / Indications for Use" and "Device Description" sections explicitly state that the lenses are used for "laser therapy of intraocular abnormalities" and "therapy of intraocular abnormalities," respectively.
Yes
The "Intended Use / Indications for Use" section explicitly states that the devices are a "family of diagnostic and therapeutic contact lenses used in the examination of the eye fundus, retina and iridocorneal and vitreous bodies". The "Device Description" also refers to them as "diagnostic and therapeutic contact lenses use for eye examination".
No
The device is described as a family of physical contact lenses, which are hardware devices, not software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The intended use and device description clearly state that these lenses are used for the examination of the eye fundus, retina, iridocorneal and vitreous bodies and for laser therapy of intraocular abnormalities. This involves direct examination and treatment of the eye itself, not analysis of a specimen taken from the body.
- The device description focuses on optical elements and visualization. The description details how the lenses provide a binocular and stereoscopic view of specific regions of the eye when used with a slit lamp. This is a diagnostic tool for direct observation, not for analyzing biological samples.
Therefore, this device falls under the category of an ophthalmic diagnostic and therapeutic device, not an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
HKS, HJL
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: 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
eye fundus, retina and iridocorneal and vitreous bodies
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
1
- 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.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/12 description: The image shows a circular logo with text around the perimeter and a stylized symbol in the center. The text around the perimeter is small and difficult to read, but it appears to be in English. The symbol in the center consists of three curved lines that resemble a stylized bird in flight. The logo is black and white and has a simple, clean design.
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.
3
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
4
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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