(58 days)
Not Found
No
The description focuses on a mechanical device for inserting an intraocular lens and does not mention any AI/ML components or functions.
No
The device is an injector used for folding and inserting an intraocular lens; it does not directly treat a disease or condition in a therapeutic manner.
No
The device is used to insert an intraocular lens and is not indicated for diagnosis.
No
The device description explicitly states it is comprised of a re-usable handheld titanium injector and a single-use disposable polypropylene cartridge, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The RxSight Insertion Device is a surgical tool used to physically insert an intraocular lens into the human eye during surgery. It does not analyze biological samples or provide diagnostic information.
- Intended Use: The intended use clearly states its purpose is for "folding and insertion of a 3-piece silicone, intraocular lens into the human eye through a surgical incision." This is a surgical procedure, not a diagnostic test.
Therefore, the RxSight Insertion Device falls under the category of a surgical instrument or medical device used in a surgical procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The RxSight Insertion Device is indicated for the folding and insertion of a 3-piece silicone, intraocular lens into the human eye through a surgical incision. The RxSight Insertion Device is only for the Bausch & Lomb LI61A0 IOL and IOL models validated for use with this device in IOL approved labeling.
Product codes (comma separated list FDA assigned to the subject device)
MSS
Device Description
The RxSight Insertion Device is a two-part IOL injector device comprised of a re-usable handheld titanium injector, and a single use, non-preloaded disposable polypropylene cartridge intended to be used to fold and insert the intraocular lenses into the eye through a small incision.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human eye
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)
The proposed device was evaluated for biocompatibility, sterilization, cleaning, sterilization residuals, shipping and handling and performance bench testing. The cleaning and sterilization cycle was validated in accordance with "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff" and covered both manual and automated cleaning processes described in the labeling for the RxSight Insertion Device. The EO sterilization cycle for the cartridge was validated in accordance with ANSI/AAMI/ISO 11135 to ensure a sterilization assurance level (SAL) of 10-6. The device will be labeled with an expiration date of 6 months from the date of sterilization.
Performance testing of the RxSight Insertion Device included pre- and post-injection evaluation of two IQLs in accordance with ISO 11979-3:2012 surgical manipulation - recovery of properties. Specifically, mechanical dimensions and sagitta were verified after the lens delivery and compared to the measurements performed prior to the lens delivery per ISO 11979-3:2012. Similarly, optical properties overall surface and bulk homogeneity were tested pre and post lens injection per ISO 11979-2:2014.
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
§ 886.4300 Intraocular lens guide.
(a)
Identification. An intraocular lens guide is a device intended to be inserted into the eye during surgery to direct the insertion of an intraocular lens and be removed after insertion is completed.(b)
Classification. Class I (general controls). Except when used as folders or injectors for soft or foldable intraocular lenses, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 886.9.
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is on the left and consists of a stylized caduceus symbol. The FDA logo is on the right and features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font size below.
July 26, 2018
RxSight, Inc. Maureen O'Connell Vice President, Clinical/Regulatory Affairs 100 Colombia Aliso Viejo, California 92656
Re: K181401
Trade/Device Name: RxSight Insertion Device Regulation Number: 21 CFR 886.4300 Regulation Name: Intraocular Lens Guide Regulatory Class: Class I Product Code: MSS Dated: May 25, 2018 Received: May 29, 2018
Dear Maureen O'Connell:
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. Please note: CDRH 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 III (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 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); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
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Page 2 - Maureen O'Connell
and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
,
for
Malvina Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose, and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K181401
Device Name RxSIGHT Insertion Device
Indications for Use (Describe)
The RxSight Insertion Device is indicated for the folding and insertion of a 3-piece silicone, intraocular lens into the human eye through a surgical incision. The RxSight Insertion Device is only for the Bausch & Lomb LI61A0 IOL and IOL models validated for use with this device in IOL approved labeling.
| 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) |
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1.0 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92(a).
| APPLICANT: | RxSight, Inc.
100 Columbia
Aliso Viejo, CA 92656 | | RxSight Insertion Device
Proposed Device | Bausch + Lomb
Injector Set
K151102
Predicate Device | AST Products
pioli IOL Delivery System
K172228
Predicate Device |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Maureen O'Connell
Vice President Clinical and Regulatory
moconnell@rxsight.com
Tel: (978) 207-1245 | Product Code | MSS | MSS | MSS |
| DATE SUMMARY
PREPARED: | July 17, 2018 | Intended Use | Intraocular Lens Delivery | Intraocular Lens Delivery | Intraocular Lens Delivery |
| TRADE NAME: | RxSight Insertion Device | Indications for Use | The RxSight Insertion Device
is indicated for the folding
and insertion of a 3-piece
silicone, intraocular lens into
the human eye through a
surgical incision. The
RxSight Insertion Device is
only for the insertion of the
Bausch & Lomb LI61A0 and
IOL models validated for use
with this device in IOL
approved labeling. | The Bausch + Lomb Injector
System is indicated for the
folding and insertion of the
Bausch + Lomb intraocular
lenses cleared or approved
for use with this IOL
Injector system. | The pioli IOL Delivery
system is a single-use, sterile
device intended to insert a
single-piece foldable
intraocular lens (IOL) into
the human eye through a
surgical procedure. The
system provides a tubular
pathway for lens implantation
through an incision. The
pioli IOL Delivery System is
only for the insertion of the
Lenstec Softec I IOL and
IOL models validated for use
with this device as indicated
in the IOL approved labeling. |
| COMMON NAME: | IOL Injector | Operating Principle | IOL placed in loading
cartridge. Cartridge snapped
into the handpiece. Screw
plunger advances the IOL
through the cartridge which
folds the IOL and advances it
into the eye. | IOL placed in loading
cartridge. Cartridge snapped
into the handpiece. Screw
plunger advances the IOL
through the cartridge which
folds the IOL and advances
it into the eye. | Cartridge is back loaded into
the injection system that
delivers the IOL through the
cartridge and into the eye |
| CLASSIFICATION NAME: | Folders and Injectors, Intraocular Lens (IOL) | Pre-loaded IOL | No | No | No |
| DEVICE CLASSIFICATION: | Class I; 21 CFR 886.4300 | Material (Injector) | Titanium | Titanium | Polypropylene |
| PRODUCT CODE: | MSS | Material (cartridge) | Polypropylene | Polyamide | LubriMATRIX™ |
| PREDICATE DEVICES: | K151102, Bausch + Lomb Injector System
K172228, pioli™ IOL Delivery System | Cartridge Coating | LubriMATRIX™ | Hydrophilic coating
(Medicoat A) | LubriMATRIX™ |
| How Supplied
(Reusable/Single Use) | Handpiece - Reusable
Cartridge - Single Use,
supplied sterile | Handpiece - Reusable
Cartridge - Single Use,
supplied sterile | Handpiece - Single Use,
disposable, supplied sterile
Cartridge - Single Use,
disposable, supplied sterile | | |
| Method of Sterilization | Handpiece - Autoclave
Cartridge - Ethylene Oxide to
SAL 10-6 | Handpiece - Autoclave
Cartridge - Ethylene Oxide
to SAL 10-6 | Ethylene Oxide to SAL 10-6 | | |
1.1 DEVICE DESCRIPTION
The RxSight Insertion Device is a two-part IOL injector device comprised of a re-usable handheld titanium injector, and a single use, non-preloaded disposable polypropylene cartridge intended to be used to fold and insert the intraocular lenses into the eye through a small incision.
1.2 INDICATIONS FOR USE
The RxSight Insertion Device is indicated for the folding and insertion of a 3-piece silicone, intraocular lens into the human eye through a surgical incision. The RxSight Insertion Device is only for the insertion of the Bausch & Lomb LI61A0 and IOL models validated for use with this device in IOL approved labeling.
1.3 TECHNOLOGICAL CHARACTERISTICS COMPARISON
The technical features of the RxSight Insertion Device and predicate devices are substantially equivalent. A comparison of the technological characteristics of these devices is provided in the table below.
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1.5 BRIEF SUMMARY OF PERFORMANCE TEST RESULTS
The descriptive characteristics are well-defined and adequate to ensure equivalence of the RxSight Insertion Device with the predicate device. Additionally, the proposed device was evaluated for biocompatibility, sterilization, cleaning, sterilization residuals, shipping and handling and performance bench testing. The cleaning and sterilization cycle was validated in accordance with "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff" and covered both manual and automated cleaning processes described in the labeling for the RxSight Insertion Device. The EO sterilization cycle for the cartridge was validated in accordance with ANSI/AAMI/ISO 11135 to ensure a sterilization assurance level (SAL) of 10-6. The device will be labeled with an expiration date of 6 months from the date of sterilization.
Performance testing of the RxSight Insertion Device included pre- and post-injection evaluation of two IQLs in accordance with ISO 11979-3:2012 surgical manipulation - recovery of properties. Specifically, mechanical dimensions and sagitta were verified after the lens delivery and compared to the measurements performed prior to the lens delivery per ISO 11979-3:2012. Similarly, optical properties overall surface and bulk homogeneity were tested pre and post lens injection per ISO 11979-2:2014.
1.6 CONCLUSION
The RxSight Insertion Device meets all product design requirements and applicable standards and embodies technological characteristics similar to the predicate devices and therefore has been shown to be substantially equivalent to the predicate device and is safe and effective for use.