(84 days)
Not Found
Not Found
No
The description focuses on the mechanical function of the device for inserting an IOL and does not mention any computational or data-driven capabilities.
No.
The device is an insertion device for an intraocular lens, not a therapeutic device itself. Its purpose is to deliver a therapeutic device (IOL) into the eye during surgery.
No
The device is described as an "insertion device" for an intraocular lens, used to "fold and deliver" the lens into the eye during cataract surgery. Its function is to facilitate the placement of a medical device, not to diagnose a medical condition.
No
The device description clearly states it is a physical, sterile, disposable plastic device consisting of a syringe-shaped tube, plunger, and transition cell, designed for folding and delivering an IOL. It is a hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "fold and deliver those IOL models that allow use of this injector in their approved labeling" and specifically mentions delivering the "Bausch & Lomb one-piece Akreos Advanced Optics Aspheric Intraocular Lens (IOL) into the eye during cataract surgery." This describes a surgical tool used in vivo (within the body) to implant a medical device (the IOL).
- Device Description: The description details a "syringe shaped tube with a plunger" and a "transition cell" designed to physically insert a lens into the eye. This is consistent with a surgical delivery system.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples from the human body (blood, urine, tissue, etc.).
- Providing information about a patient's health status, diagnosis, or disease.
- Using reagents or assays.
Therefore, the Akreos Single Use Insertion Device is a surgical instrument used for the delivery of an intraocular lens, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The intended use for the Akreos Single Use Insertion Device, Model AI-28 is to fold and deliver a Bausch & Lomb IOL into the eye during normal small incision cataract surgery.
The Akreos Single Use Insertion Device should only be used to fold and deliver those IOL models that allow use of this injector in their approved labeling.
Product codes (comma separated list FDA assigned to the subject device)
KYB
Device Description
Akreos Single Use Insertion Device, Model AI-28, previously known as Hydroport SI, is validated for folding and delivering the Bausch & Lomb one-piece Akreos Advanced Optics Aspheric Intraocular Lens (IOL) into the eye during cataract surgery. Future IOL models may also by qualified with the Akreos Single Use Insertion Device following fold and recovery validation studies.
The device provides a small tubular pathway in which the Akreos Advanced Optics Aspheric Lens can be placed into the eye with one continuous forward motion. The Akreos Single Use Insertion Device consists of two parts: a syringe shaped tube (includes lens loading deck and lens cap) with a plunger, and a transition cell.
The Akreos Single Use Insertion Device is a sterile (EtO), disposable plastic device, designed for single use only.
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)
Substantial equivalence is based on non-clinical performance data that show that the subject device met the acceptance criteria for fold and recovery testing of the Akreos Aspheric Optic IOL using the same principle of operation as the predicate device. Stability testing for the plunger material met the acceptance criteria showing no significant shifts in tensile and flexural properties following sterilization.
The Akreos Single Use Insertion Device, Model AI-28 was shown to be safe using the results of the biocompatibility testing for the polypropylene material as well as polyphthalamide, the new plunger material. Sterilization and Shelf-life test results confirm that the subject device is substantially equivalent to the marketed predicate device.
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.
Passport foldable lens placement system
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
Bausch & Lomb ...
510(k) Summary
MAR 0 7 2007
Akreos Single Use Insertion Device, Model AI-28
| Submitter
Information | Owner: | Bausch & Lomb, Incorporated
180 Via Verde
San Dimas, CA 92886 |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------|
| | Telephone:
Fax: | 909 971 5394
909 971 5148 |
| | Contact: | Nanette Canepa
Associate Manager, Global Regulatory Affairs |
| Date Prepared | December 12, 2006 | |
| Subject device
name | Trade name: Akreos Single Use Insertion Device, Model AI-28
Common name: Lens insertion guide
Classification name: Intraocular lens guide (21CFR 886.4300,
Product Code KYB) | |
| Predicate
device | Passport foldable lens placement system | |
Continued on next page
:
1
| Subject device description | Akreos Single Use Insertion Device, Model AI-28, previously
known as Hydroport SI, is validated for folding and delivering the
Bausch & Lomb one-piece Akreos Advanced Optics Aspheric
Intraocular Lens (IOL) into the eye during cataract surgery. Future
IOL models may also by qualified with the Akreos Single Use
Insertion Device following fold and recovery validation studies. |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The device provides a small tubular pathway in which the Akreos
Advanced Optics Aspheric Lens can be placed into the eye with one
continuous forward motion. The Akreos Single Use Insertion Device
consists of two parts: a syringe shaped tube (includes lens loading
deck and lens cap) with a plunger, and a transition cell. |
| | The Akreos Single Use Insertion Device is a sterile (EtO),
disposable plastic device, designed for single use only. |
| Technological characteristics | The similarities between the Akreos Single Use Insertion Device,
Model AI-28 and the Passport foldable lens placement system are
the overall design, components, intended use, operating principle,
folding direction of the lens, cartridge design, sterilization methods
and component materials with the exception of the plunger material. |
| | The change in plunger material of the subject device has not altered
the fundamental scientific technology of the predicate device. |
| Intended use | The intended use for the Akreos Single Use Insertion Device, Model
AI-28 is to fold and deliver a Bausch & Lomb IOL into the eye
during normal small incision cataract surgery. |
Continued on next page
2
Labeling The labeling for the Akreos Single Use Insertion Device, Model AI-28 and the Passport foldable lens placement system differ in the type of intraocular lens specified for use. These differences in the labeling that specify use, do not affect safety and effectiveness of the device when used as labeled because each insertion device is specifically made to fit the size and shape of the indicated intraocular lens. Substantial Substantial equivalence is based on non-clinical performance data Equivalence that show that the subject device met the acceptance criteria for fold discussion and recovery testing of the Akreos Aspheric Optic IOL using the same principle of operation as the predicate device. Stability testing for the plunger material met the acceptance criteria showing no significant shifts in tensile and flexural properties following sterilization. Therefore, the effectiveness is demonstrated for the indicated use of the subject device. -The Akreos Single Use Insertion Device, Model AI-28 was shown to be safe using the results of the biocompatibility testing for the polypropylene material as well as polyphthalamide, the new plunger material. Sterilization and Shelf-life test results confirm that the subject device is substantially equivalent to the marketed predicate device. Conclusion Based on the 510(k) summary and the information provided herein, we conclude that the modified device is substantially equivalent to the predicate device, is safe and effective under the Federal Food, Drug and Cosmetic Act.
3
Image /page/3/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 three lines representing its body and wings. The eagle is positioned to the right of a circular text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged around the circumference of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Bausch & Lomb c/o Ms. Nanette Canepa Associate Manager, Global Regulatory Affairs 180 E. Via Verde Drive San Dimas, CA 91773
MAR 0 7 2007
Re: K063694
Trade/Device Name: Akreos Single Use Insertion Device Regulation Number: 21 CFR 886.4300 Regulation Name: Intraocular Lens Guide Regulatory Class: Class I Product Code: KYB Dated: February 7, 2007 Received: February 8, 2007
Dear Ms. Canepa:
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. Ilsting 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 such 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
4
Page 2 – Ms. Nanette Canepa
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,
M.B. Eichelman SimD
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
5
Indications for Use
510(k) Number (if known):
Device Name:
Indications For Use:
Akreos Single Use Insertion Device
The Akreos Single Use Insertion Device should only be used to fold and deliver those IOL models that allow use of this injector in their approved labeling.
Prescription Use (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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
.
(Division Sign-Off) Division of Ophthalmic Ear, Nose and Throat Devises
Page 1 of __
510(k) Number K063694