(283 days)
The xact™ foldable lens inserter is a device intended to fold the AVS 3-piece foldable lens, 6mm or 7mm optic, and assisting in placing it into the capsular bag of the eye to replace the natural crystalline lens during normal smallincision cataract surgery. It provides a small tubular pathway in which the foldable lens can be placed into the eye with a continuous forward motion.
The xact lens inserter (Model 6mm / 7mm) is a light weight plastic, single use, disposable device. It has a multi piece design, with an injector/handpiece unit and a separate cartridge.
The lens is delivered manually by action of the plunger. The final delivery is done by a screwthread action. The final injection needs 2- 3 turns with screw thread until the final position of the plunger. The plunger allows for forward and backward action during delivery. The front end of the plunger is visible during delivery.
The lens inserter (Model 6mm / 7mm) is for both handed use: one hand for gripping and directing, while activating the plunger with the other. The plunger doesn't rotate inside the handpiece.
The lens is rolled rather than folded. The cartridge or rolling/folding mechanism locks in place on the handpiece.
The provided text contains information about a 510(k) summary for the xact™ Injector, an intraocular lens inserter. However, it does not include the specific details required to answer your questions about acceptance criteria, a study proving device meeting criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.
The document only states that:
"The xact™ lens inserter (Model 6mm / 7mm) has been tested in vitro for proper functioning under various conditions of use. The results of these performance tests demonstrate that the xact™ lens inserter (Model 6mm / 7mm) reliably delivers the Advanced Vision Science® 3-piece foldable lens without impacting the optical performance, the dimensions or the cosmetic appearance of the lens."
This statement confirms that performance tests were conducted and the device met certain functional requirements related to lens delivery and preservation of lens quality. However, it does not provide the specific "acceptance criteria" or the detailed "study" information requested.
Therefore, I cannot fill in the table or provide the specific details for the requested points based solely on the provided text. The document is a 510(k) summary, which often summarizes testing results without detailing the methodology or specific acceptance criteria in the public-facing document.
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510(k) Summary for the xact™ Injector
JUL - 9 2009
Name and Address of Sponsor
SIS Surgical Instrument Systems Ltd. Registration Number: 9614468 Allmendstrasse 11 2502 Port Switzerland Phone: 0041 32 332 70 70 Fax: 0041 32 332 70 71 Email: frank.ziemer@sisItd.ch
Name and Address of Manufacturer
SIS Surgical Instrument Systems Ltd. Registration Number: 9614468 Allmendstrasse 11 2502 Port Switzerland Phone: 0041 32 332 70 70 Fax: 0041 32 332 70 71 Email: frank.ziemer@sisItd.ch
Name and Address of Official Correspondent
Kevin Walls, RAC Principal Consultant Regulatory Insight, Inc. 5401 S. Cottonwood Ct. Greenwood Village, CO 80121 Phone: 720-962-5412 Fax: 720-962-5413 Email: kevin@reginsight.com
Device Name
Device trade name: xact™ lens inserter Common/Classification name: Intraocular Lens Folder and Injector
Classification, Panel and Product Code
| Device Classification: | Class 1 (reserved), MSS |
|---|---|
| Reviewing Panel: | Ophthalmic Devices |
| Classification Code: | 21 CFR Part 886.4300 |
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Indications for Use
The xact™ foldable lens inserter (Model 6mm / 7mm) is a device intended to fold the Advanced Vision Science® 3-piece foldable lens and assisting in placing it into the capsular bag of the eye to replace the natural crystalline lens during normal small-incision cataract surgery. It provides a small tubular pathway in which the foldable lens can be placed into the eye with a continuous forward motion.
Device Description
The xact lens inserter (Model 6mm / 7mm) is a light weight plastic, single use, disposable device. It has a multi piece design, with an injector/handpiece unit and a separate cartridge.
The lens is delivered manually by action of the plunger. The final delivery is done by a screwthread action. The final injection needs 2- 3 turns with screw thread until the final position of the plunger. The plunger allows for forward and backward action during delivery. The front end of the plunger is visible during delivery.
The lens inserter (Model 6mm / 7mm) is for both handed use: one hand for gripping and directing, while activating the plunger with the other. The plunger doesn't rotate inside the handpiece.
The lens is rolled rather than folded. The cartridge or rolling/folding mechanism locks in place on the handpiece.
Substantial Equivalence
The predicate devices which we are claiming substantial equivalence to are:
- Micro STAAR™ Injector MSI-P1 (K983129) ।
- the CeeOn™ EASYSERT (K002556) l
- the MONARCH ® II IQL (K003768) ।
Performance data
The xact™ lens inserter (Model 6mm / 7mm) has been tested in vitro for proper functioning under various conditions of use. The results of these performance tests demonstrate that the xact™ lens inserter (Model 6mm / 7mm) reliably delivers the Advanced Vision Science® 3-piece foldable lens without impacting the optical performance, the dimensions or the cosmetic appearance of the lens.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its head facing left and its wings forming three stripes. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SIS Surgical Instrument Systems Ltd. c/o Mr. Kevin Walls, RAC Principal Consultant Regulatory Insight, Inc. 5401 S. Cottonwood Court Greenwood Village, CO 80121
JUL - 9 2009
Re: K082871
Trade Name: xact™ lens inserter system Regulation Number: 21 CFR 886.4300 Regulation Name: Intraocular lens guide Regulatory Class: Class I (reserved) Product Code: MSS Dated: June 10, 2009 Received: June 11, 2009
Dear Mr. Walls:
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 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 (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.
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Page 2 - Mr. Kevin Walls, RAC
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Jot Callaway for
Malvina B. Eydelman, M.D.
Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): _KO82821
Device Name: xact™ Lens Inserter
Indications:
The xact™ foldable lens inserter is a device intended to fold the AVS 3-piece foldable lens, 6mm or 7mm optic, and assisting in placing it into the capsular bag of the eye to replace the natural crystalline lens during normal smallincision cataract surgery. It provides a small tubular pathway in which the foldable lens can be placed into the eye with a continuous forward motion.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kesia Alexander
(Division Sign-Off)
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K082871 Page 1 of 1
§ 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.