(292 days)
Not Found
No
The summary describes a mechanical device for inserting lenses and makes no mention of AI or ML.
No
The device is described as a placement system for intraocular lenses, which aids in the surgical procedure but does not directly treat a disease or condition itself. It's an instrument for insertion rather than a therapeutic agent.
No
Explanation: The device is described as a "Lens Placement System" used for "compressing and inserting" an intraocular lens, which is a therapeutic or surgical function, not a diagnostic one.
No
The device description clearly states it is a "single use only disposable device" made of "polypropylene," indicating it is a physical, hardware-based medical device for inserting intraocular lenses.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to compress and insert an intraocular lens into the eye during surgery. This is a surgical device used in vivo (within a living organism).
- Device Description: The description reinforces its use in surgery for lens placement.
- Anatomical Site: The anatomical site is the eye, which is a part of the living body.
- Lack of IVD Characteristics: There is no mention of analyzing samples in vitro (outside the body), such as blood, urine, tissue, etc., to diagnose a condition or provide information about a physiological state.
IVD devices are used to examine specimens obtained from the human body to provide information for diagnosis, monitoring, or screening. This device is a surgical tool used directly on the patient's eye.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
86 MSS
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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 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.
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
November 5, 1997 Amendment to Premarket Notification #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
-
- 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
-
- Name of Device, including trade name and classification name:
- Trade/Proprietary Name: Mport™ Foldable Lens Placement System a.
- b. Classification Name: Intraocular Lens Guide
-
- 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
1
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):
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).
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 a
Soflex™ IOL into the eye
during normal small incision
cataract surgery | Same |
| Operating Principle | Loads IOL into the
inserter mechanically
and inserts IOL into the
eye. IOL delivered by
rotating a screw device
creating forward motion. | Same IOL delivered by direct
forward motion applied
to a syringe-type
plunger |
| Folding Operation
(Refer to comparison
pictures in Section 9 and
Directions for Use in
Section 7) | IOL is loaded into cartridge
and closed. Apposing
contact edges are folded
toward each other. | IOL is loaded flat in
unstressed state and
laterally compressed by the
closure of a slider. Contact
edges are maintained in the
same plane. |
| Folding direction of the lens | Lens unfolds facing up
(taco up) | Lens decompresses in a
horizontal plane |
| Cartridge design | Single-piece (insertion
chamber) | None |
Comparative Technological Characteristics
2
continued
| CHARACTERISTICS | MICROSERT™
(PREDICATE) | MPORT™ |
|---------------------------------------|------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|
| Sterilization method | EO for cartridge and
accepted surgical method
for inserter handpiece. | EO for entire device |
| Materials | • Polypropylene
disposable cartridge
• Titanium reusable
handpiece. | • Polypropylene
disposable tube, slide
pusher and jackets.
• Silicone o-ring |
| Surface treatment | None | None |
| *Patient contact portion of
device | Cartridge tip and handpiece
tip | 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.
3
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.
4
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
5
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:
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.
(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)