The Mport™ Foldable Lens Placement System is a Class I device indicated for compressing and inserting a Soflex™ (formerly Chiroflex II) series multi-piece intraocular lens into the eye during small incision cataract surgery.

Device Description

The Mport™ Foldable Lens Placement System is a device designed to compress and insert a Soflex™ multipiece foldable intraocular lens into the eye during normal small incision cataract surgery. The Mport™ is a single use only disposable device. The Mport™ materials the same as those materials used in the lens/patient contacting cartridge of the predicate device (polypropylene).

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Mport™ Foldable Lens Placement System:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
No negative impact on lens diopter	Optical specifications measured before and after lens delivery showed no negative impact to the lens.
No negative impact on lens resolution	Optical specifications measured before and after lens delivery showed no negative impact to the lens.
No negative impact on cosmetic appearance of the lens	Optical specifications measured before and after lens delivery showed no negative impact to the lens.
Biocompatibility	Biocompatibility testing supported that technological changes do not raise new safety issues.
Sterilization effectiveness	Sterilization studies supported that technological changes do not raise new safety or effectiveness issues.
Acceptable for delivery of Soflex™ multi-piece lenses	The Mport™ Foldable Lens Placement System was found to be acceptable for delivery of Chiron's Soflex™ multi-piece lenses.
No new issues of safety or effectiveness	Biocompatibility testing and sterilization studies support the fact that the technological changes in the Mport™ system do not raise any new issues of safety, effectiveness or performance of the product.
Proper functioning in accordance with Directions for Use	Performance was evaluated "when used in accordance with the directions for use."

Explanation of "Implied" Criteria: The document does not explicitly list "acceptance criteria" with numerical thresholds. Instead, it states that various tests "showed no negative impact" or "supported the fact that technological changes do not raise any new issues," which serves as the de-facto acceptance standard for substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a distinct "test set" sample size for the studies mentioned. The testing summarized appears to be a series of non-clinical, bench-top tests rather than human subject trials with a defined test set.

Data Provenance: Not explicitly stated. Given the nature of the device (a lens insertion system) and the tests performed (optical specifications, biocompatibility, sterilization), the data is most likely from laboratory and bench testing, rather than human clinical data. The country of origin is not mentioned, but the submitting company is Chiron Vision Corporation in Claremont, California, USA, suggesting the testing was likely conducted in the US or under US regulatory guidance. The studies are retrospective in the sense that they were conducted before the 510(k) submission to demonstrate the device's characteristics.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. The ground truth for the non-clinical tests described would be derived from objective measurements and scientific principles (e.g., optical measurement standards, biocompatibility guidelines, sterilization efficacy standards), not human expert consensus on a test set.

4. Adjudication Method for the Test Set

Not applicable. There is no mention of a human-adjudicated test set in this non-clinical evaluation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices where human readers interpret medical images or data. The Mport™ is a surgical tool for inserting an intraocular lens.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable in the context of an AI algorithm. The device itself is a mechanical-surgical tool. The "standalone" performance here refers to the device's ability to compress and insert the lens without causing damage or issues, which was evaluated through the non-clinical tests.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests was based on:

Objective Measurements/Standards: For optical specifications (diopter, resolution, cosmetic appearance), it would be against predefined optical engineering standards and specifications for the lens.
Biocompatibility Standards: Adherence to established ISO or ASTM standards for materials in contact with the body.
Sterilization Efficacy Standards: Adherence to established standards for ethylene oxide (EO) sterilization.
Functional Adequacy: The ability to successfully deliver the lens without damage, as per the device's intended function.

8. The Sample Size for the Training Set

Not applicable. This device is a mechanical tool, not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device.

Summary

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November 5, 1997 Amendment to Premarket Notification #K970727

K970727

Summary of Safety and Effectiveness

DEC 17 1997

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and CFR 807.92

1. Submitter's name, address, telephone, contact person and date summary was prepared:
- Chiron Vision Corporation a. 555 West Arrow Highway Claremont, California 91711
- b. Contact Person:

Judy F. Gordon, D. V. M. Senior Vice President, Research and Development

Jan Champion for

c. Date Summary Prepared: November 5, 1997

1. Name of Device, including trade name and classification name:
- Trade/Proprietary Name: Mport™ Foldable Lens Placement System a.
- b. Classification Name: Intraocular Lens Guide
1. Identification of the predicate device or legally marketed device or devices to which substantial equivalence is being claimed:
- Company: Chiron Vision Corporation

Device: Microsert™ Foldable Lens Placement System

510(k) K914311

Date Cleared June 2, 1995

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A description of the device that is the subject of the 510(k), including 4. explanation of how the device functions, basic scientific concepts, significant physical and performance characteristics (design, material, physical properties):

5. Statement of intended use:

The Mport™ Foldable Lens Placement System is intended to be used to compress and insert a Soflex™ multipiece intraocular lens into the capsular bag.

Statement of how the technological characteristics of the device compare 6. to those of the predicate or legally marketed device.

CHARACTERISTICS	MICROSERT™(PREDICATE)	MPORT™
Intended Use	Folds and delivers aSoflex™ IOL into the eyeduring normal small incisioncataract surgery	Same
Operating Principle	Loads IOL into theinserter mechanicallyand inserts IOL into theeye. IOL delivered byrotating a screw devicecreating forward motion.	Same IOL delivered by directforward motion appliedto a syringe-typeplunger
Folding Operation(Refer to comparisonpictures in Section 9 andDirections for Use inSection 7)	IOL is loaded into cartridgeand closed. Apposingcontact edges are foldedtoward each other.	IOL is loaded flat inunstressed state andlaterally compressed by theclosure of a slider. Contactedges are maintained in thesame plane.
Folding direction of the lens	Lens unfolds facing up(taco up)	Lens decompresses in ahorizontal plane
Cartridge design	Single-piece (insertionchamber)	None

Comparative Technological Characteristics

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continued

CHARACTERISTICS	MICROSERT™(PREDICATE)	MPORT™
Sterilization method	EO for cartridge andaccepted surgical methodfor inserter handpiece.	EO for entire device
Materials	• Polypropylenedisposable cartridge• Titanium reusablehandpiece.	• Polypropylenedisposable tube, slidepusher and jackets.• Silicone o-ring
Surface treatment	None	None
*Patient contact portion ofdevice	Cartridge tip and handpiecetip	Tube tip and pusher tip

Brief summary of nonclinical tests and results: 7.

The Moort™ Foldable Lens Placement System was found to be acceptable for delivery of Chiron's Soflex™ multi-piece lenses. The use of the Mport™ for delivery of Soflex lenses has no impact on lens diopter, resolution or cosmetic appearance of the lens when used in accordance with the directions for use. Optical specifications measured before and after lens delivery showed no negative impact to the lens from the use of the Mport™ delivery system. Biocompatibility testing and sterilization studies support the fact that the technological changes in the Mport™ system do not raise any new issues of safety, effectiveness or performance of the product.

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DEC 17 1997

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Judy F. Gordon, D.V.M. Senior Vice President, Research and Development Chiron Vision Corporation 555 West Arrow Hwy. Claremont, CA 91711

Re: K970727 Trade Name: Mport™ Foldable Lens Placement System Regulatory Class: I Product Code: 86 MSS Dated: November 5, 1997 Received: November 6, 1997

Dear Dr. Gordon:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

Image /page/3/Picture/8 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other.

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Page 2 - Judy F. Gordon, D.V.M.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on. the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

A. Ralph Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Chiron Vision Corporation Mport™ Foldable Lens Placement System

Image /page/5/Picture/2 description: The image shows the text '510(k) Number (if known):' followed by the number 'K970727'. The text indicates that this is a 510(k) number, which is a premarket submission made to the FDA to demonstrate that the device to be marketed is safe and effective. The number 'K970727' is likely the specific identification number assigned to the device in question. The number is handwritten and underlined.

Device Name:

Mport™, Foldable Lens Insertion System

Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dmns lochner
(Division Sign-Off)

Division of Ophthalmic Devices
510(k) Number K976727

Prescription Use X

OR Over-The-Counter Use

(Per 21 CFR 801.109)

Regulation Number and Section

§ 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.