(122 days)
No
The device description and performance studies focus on the mechanical function of folding and inserting an IOL, with no mention of AI/ML terms or capabilities.
No.
The device is used to assist in the insertion of an intraocular lens and is not directly involved in treating a disease or condition itself.
No
The device is used to insert intraocular lenses, which is a therapeutic rather than a diagnostic function. It assists in a surgical procedure, it does not diagnose a condition.
No
The device description explicitly states it is a physical cartridge made of polypropylene, used in conjunction with a reusable titanium handpiece, and is provided sterile. This indicates it is a hardware medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to fold and assist in inserting an intraocular lens into the eye. This is a surgical procedure performed on the patient, not a test performed on a sample taken from the patient.
- Device Description: The device is a cartridge used to deliver an IOL into the eye. It's a tool for a surgical procedure.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting substances, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device clearly falls outside of that definition.
N/A
Intended Use / Indications for Use
Used to fold and assist in inserting TECNIS® 1-Piece intraocular lenses into the eye.
Product codes (comma separated list FDA assigned to the subject device)
MSS, KYB
Device Description
The One Series™ Ultra cartridge is used to fold and assist in the insertion of a TECNIS® 1-Piece soft acrylic intraocular lens (IOL) into the eye following cataract extraction. The cartridge, Model 1VIPR30 is a single-use component composed of polypropylene which is injection molded and coated with a lubricious coating. The cartridge is provided sterile. The IOL is loaded into the proximal portion of the cartridge using forceps. The cartridge is then placed in a reusable titanium handpiece, which advances the IOL through the tube section of the cartridge and delivers it into the eye.
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)
Bench testing and biocompatibility testing were conducted which verified that the material and performance characteristics (folding, delivery, and retention of IOL cosmetic, dimensional, and optical properties) associated with the One Series™ Ultra cartridge were equivalent to that of the predicate devices.
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.
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 & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right is the FDA logo, with the letters "FDA" in a blue square, followed by "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
September 20, 2021
Advanced Medical Optics, Inc. Ms. Kim Regis Manager, Regulatory Affairs Projects 1700 East St. Andrew Pl. Santa Ana, California 92705
Re: K081545
Trade/Device Name: ONE SERIESTM Ultra Cartridges Regulation Number: 21 CFR 886.4300 Regulation Name: Intraocular lens guide Regulatory Class: Class I, reserved Product Code: MSS
Dear Ms. Kim Regis:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated October 2, 2008. Specifically, FDA is updating this SE Letter to include the correct product code as an administrative correction. Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Bennett Walker, Ph.D., OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices, 301-796-5094, bennett.walker(@fda.hhs.gov .
Sincerely,
Bennett N. Digitally signed by
Bennett N. Bennett N. Walker -S Date: 2021.09.20 Walker -S 09:14:14 -04'00'
Bennett Walker, Ph.D. Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized eagle with three wavy lines representing its body and wings. The eagle faces right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
OCT 02 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Advanced Medical Optics, Inc. c/o Ms. Kim Regis Manager, Regulatory Affairs Projects 1700 E. St. Andrew Place Santa Ana, CA 92705
Re: K081545 Trade Name: ONE SERIES™ ULTRA Cartridges Regulation Number: 21 CFR 886.4300 Regulation Name: Intraocular lens guide Regulatory Class: I Product Code: KYB Dated: September 25, 2008 Received: September 26, 2008
Dear Ms. Regis:
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. Iisting 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.
2
Page 2 - Ms. Kim Regis
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,
Malvina B. Eggleston, M.D.
Malvina B. Eydelman M.I Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
CDRH INDICATIONS FOR USE
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name(s): Indications for Use: One Series™ Ultra cartridge
Used to fold and assist in inserting TECNIS® 1-Piece intraocular lenses into the eye.
| Prescription Use | X (Part 21 CFR 801 Subpart D) |
|---|---|
| AND/OR | |
| Over-The-Counter Use | (21 CFR 807 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 | |
| 510(k) Number | K081545 |
Page 1 of 1
4
Image /page/4/Picture/1 description: The image shows the logo for Advanced Medical Optics (AMO). The logo features a stylized "AMO" in bold, sans-serif font, with a curved line above the letters. Below the letters, the words "ADVANCED MEDICAL OPTICS" are printed in a smaller, sans-serif font.
OCT 02 2008
5.0 510(k) SUMMARY
This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92(c).
-
- Submitter's name, address, telephone number, contact person, and date summary prepared:
| a. Applicant: | Advanced Medical Optics, Inc.
1700 E. St. Andrew Place
Santa Ana, CA 92705 |
|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| b. Contact Person: | Kim Regis
Manager, Regulatory Affairs Projects
1700 E. St. Andrew Place
Santa Ana, CA 92705
Ph: 714.247.8564
Fax: 714.247.8677 |
- c. Date Summary Prepared: May 30, 2008
2. Name of device, including trade name and classification name:
| a. Trade/Proprietary Name: | One Series™ Ultra cartridge |
|---|---|
| b. Classification Name: | Intraocular Lens Guide |
| c. Device Classification: | Class I per 21 CFR 886.4300 |
| d. Product Code: | KYB |
-
- Identification of the predicate device or legally marketed device or devices to which substantial equivalence is being claimed:
| Company: | Advanced Medical Optics, Inc. (AMO®) |
|---|---|
| Device: | AMO® PhacoSert™ cartridge |
| 510(k): | K961242 |
| Date Cleared: | June 17, 1996 |
| Company: | IntraLuminal Therapeutics, Inc. |
| Device: | Safe-Cross® Deflecting Catheter |
| 510(k): | K031692 |
| Date Cleared: | August 22, 2003 |
5
-
- A description of the device that is the subject of the 510(k), including explanation of how the device functions, basic scientific concepts, significant physical and performance characteristics (design, material, physical properties):
The One Series™ Ultra cartridge is used to fold and assist in the insertion of a TECNIS® 1-Piece soft acrylic intraocular lens (IOL) into the eye following cataract extraction. The cartridge, Model 1VIPR30 is a single-use component composed of polypropylene which is injection molded and coated with a lubricious coating. The cartridge is provided sterile. The IOL is loaded into the proximal portion of the cartridge using forceps. The cartridge is then placed in a reusable titanium handpiece, which advances the IOL through the tube section of the cartridge and delivers it into the eye.
- A description of the device that is the subject of the 510(k), including explanation of how the device functions, basic scientific concepts, significant physical and performance characteristics (design, material, physical properties):
5. Statement of intended use:
The One Series™ Ultra cartridge is used to fold and assist in the insertion of a TECNIS® 1-Piece soft acrylic intraocular lens (IOL) into the eye.
6. Statement of how the technological characteristics of the device compare to those of the predicate or legally marketed device.
The technological characteristics of the One Series™ Ultra cartridge were compared to those of the predicate devices and were found to be equivalent with respect to materials, method of sterilization, intended use, and/or mode of operation.
7. Brief summary of nonclinical tests and results:
Bench testing and biocompatibility testing were conducted which verified that the material and performance characteristics (folding, delivery, and retention of IOL cosmetic, dimensional, and optical properties) associated with the One Series™ Ultra cartridge were equivalent to that of the predicate devices.
8. Conclusions:
AMO has demonstrated through its evaluation of the One Series™ Ultra cartridge that the device is equivalent to the predicate devices with respect to intended use. technological characteristics, and safety and effectiveness.
6
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/6/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized eagle with three wavy lines representing its body and wings. The eagle faces right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
OCT 02 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Advanced Medical Optics, Inc. c/o Ms. Kim Regis Manager, Regulatory Affairs Projects 1700 E. St. Andrew Place Santa Ana, CA 92705
Re: K081545 Trade Name: ONE SERIES™ ULTRA Cartridges Regulation Number: 21 CFR 886.4300 Regulation Name: Intraocular lens guide Regulatory Class: I Product Code: KYB Dated: September 25, 2008 Received: September 26, 2008
Dear Ms. Regis:
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. Iisting 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.
7
Page 2 - Ms. Kim Regis
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,
Malvina B. Eggleston, M.D.
Malvina B. Eydelman M.I Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
8
CDRH INDICATIONS FOR USE
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name(s): Indications for Use: One Series™ Ultra cartridge
Used to fold and assist in inserting TECNIS® 1-Piece intraocular lenses into the eye.
| Prescription Use | X (Part 21 CFR 801 Subpart D) |
|---|---|
| AND/OR | |
| Over-The-Counter Use | (21 CFR 807 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 | |
| 510(k) Number | K081545 |
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