(118 days)
Not Found
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI or ML.
No
This device is for folding and inserting intraocular lenses (IOLs) and does not directly treat a disease or condition, making it a delivery system rather than a therapeutic device.
No
The device description indicates that the Aero Z Cartridge IOL Delivery System is used to fold and insert IOLs into the eye. This is an interventional/delivery function, not a diagnostic one.
No
The device description clearly states it is a two-part device comprised of a reusable handpiece (titanium) and a single-use disposable cartridge (polypropylene), indicating it is a physical medical device with hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "fold and insert Aaren Scientific IOLs... into the eye." This describes a surgical delivery system for an implantable device (an intraocular lens), not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The device is a mechanical system for delivering a lens into the eye. It does not involve reagents, samples, or analysis of biological material.
- Anatomical Site: The device is used to deliver a lens to the "Posterior chamber of the eye," which is an in-vivo application, not an in-vitro test.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Aero Z Cartridge IOL Delivery System is indicated to fold and insert Aaren Scientific IOLs that have the use of this inserter in their approved labeling.
Product codes (comma separated list FDA assigned to the subject device)
MSS
Device Description
The Aero Z Cartridge IOL Delivery System is a two-part device comprised of a reusable handpiece and single use disposable cartridge. The single use disposable cartridge is , fabricated from polypropylene with a glyceryl monostearate (GMS) agent incorporated for lubricity. It is intended for single use only and is provided sterile. The reusable handpiece is titanium, is supplied non-sterile and is designed to accommodate the cartridge and lens for delivery of the lens into the eye. The reusable handpiece is supplied in both a push-and-turn and screw type configuration.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Posterior chamber of the 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)
In accordance with ISO 10993-1:2009, cytotoxicity, sensitization and irritation testing were performed on the IOL Delivery System. The device was found to be non-cytotoxic. non-sensitizing, and non-irritating. Testing conducted in accordance with ISO 11979-3 demonstrated that the Aero Z Cartridge IOL Delivery System can deliver IOL Models EC-3 and EC-3 PAL without significantly impacting the optical or mechanical performance, dimensions or the cosmetic appearance of the lens.
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
S10(K) Summary
APR 1 5 2013
Submitter's Name, Address, Telephone Number, Contact Person, and Date 5.1 Summary Prepared
| A. | Company Name: | Aaren Scientific Inc. |
|---|---|---|
| B. | Company Address: | 4290 E. Brickell St., Bldg. A. |
| Ontario, CA 91761 | ||
| C. | Company Phone: | 1 (909) 937-1033 |
| D. | Contact Person: | Robert K. Sheehan |
| Vice President, Regulatory Affairs and | ||
| Quality Systems | ||
| Aaren Scientific Inc. | ||
| 4290 East Brickell St., Bldg. A |
Ontario, CA 91761 USA
Phone +1 (909) 937-1033 ext. 108 Email: rksheehan@aareninc.com
5.2 Date Summary Prepared
January 5, 2013
Name of Device, Including Trade Name and Classification Name 5.3 A. Device Trade Name: Aero Z Cartridge IOL Delivery System B. Common Name: Small Incision Injector ். Classification Name(s): Intraocular lens guide D. Classification Regulation: 21 CFR 886.4300 Class I E. Product Code: MSS F. Advisory Panel: Ophthalmic
1
5.4 Predicate Devices
The Aero Z Cartridge IOL Delivery System is substantially equivalent to the Monarch III IOL Delivery System (C Cartridge) device cleared under 510(k) K112977 with respect to indications for use, materials and mechanism of action.
Device Description ર્સ્ડ
The Aero Z Cartridge IOL Delivery System is a two-part device comprised of a reusable handpiece and single use disposable cartridge. The single use disposable cartridge is , fabricated from polypropylene with a glyceryl monostearate (GMS) agent incorporated for lubricity. It is intended for single use only and is provided sterile. The reusable handpiece is titanium, is supplied non-sterile and is designed to accommodate the cartridge and lens for delivery of the lens into the eye. The reusable handpiece is supplied in both a push-and-turn and screw type configuration.
5.6 Indications for Use
The Aero Z Cartridge IOL Delivery System is indicated to fold and insert Aaren Scientific IOLs that have the use of this inserter in their approved labeling.
5.7 Comparison of Technological Characteristics
The Aero Z Cartridge IOL Delivery System has the same indications for use, materials and mechanism of action as the predicate device (Alcon Research Monarch III IOL Delivery System, C Cartridge) device.
2
| Table 3.1: Comparison of Z Cartridge IOL Delivery System with Predicate Device | ||
|---|---|---|
| Device Name | Aaren Scientific | |
| Z Cartridge IOL Delivery | ||
| System | Alcon Research | |
| Monarch® III IOL Delivery | ||
| System (C Cartridge) | ||
| 510(k) Number | K123888 | K112977 |
| Substantial Equivalence Characteristics | ||
| Intended Use | The Z Cartridge IOL Delivery | |
| System is indicated to fold and | ||
| insert Aaren Scientific Models | ||
| EC-3 and EC-3 PAL intraocular | ||
| lenses into the posterior | ||
| chamber of the eye | Folding and injection of | |
| AcrySof® intraocular lenses | ||
| into the posterior chamber of | ||
| the eye | ||
| Anatomical Site of Use | Posterior chamber of the eye | Posterior chamber of the eye |
| Components | Reusable handpiece and single- | |
| use, sterile Cartridge | Reusable handpiece and single- | |
| use, sterile Cartridge | ||
| Handpiece | ||
| Material | Titanium alloy | Titanium alloy |
| Lens Injecting Mechanism | Syringe-like (Push style) and | |
| Push-and-turn rotational | ||
| (Screw style) | Push and turn | |
| Configuration | Barrel and plunger assembly, | |
| the barrel has a chamber to | ||
| accept the Cartridge and the | ||
| plunger advances the lens for | ||
| injection | Barrel and plunger assembly, | |
| the barrel has a chamber to | ||
| accept the Cartridge and the | ||
| plunger advances the lens for | ||
| injection | ||
| Sterilization | Flash autoclave or steam | |
| sterilization by user | Flash autoclave or steam | |
| sterilization by user | ||
| Cartridge | ||
| Material | Polypropylene with a glycerol | |
| monostearate (GMS) lubricity | ||
| agent | Polypropylene with a | |
| polyvinylpyrrolidone (PVP) | ||
| coating on the inner lumen | ||
| Loading Chamber | Lumen with wings for folding | Internal Cartridge |
| geometry | ||
| Configuration | Lens loading and folding area | |
| connected to a lens injecting | ||
| nozzle | Lens loading and folding area | |
| connected to a lens injecting | ||
| nozzle | ||
| Sterilization | Ethylene oxide (EtO) | Ethylene oxide (EtO) |
.
Table 5.1: Comparison of Z Cartridge IOL Delivery System with Predicate Device
.
3
Brief Summary of Nonclinical Tests and Results 5.8
In accordance with ISO 10993-1:2009, cytotoxicity, sensitization and irritation testing were performed on the IOL Delivery System. The device was found to be non-cytotoxic. non-sensitizing, and non-irritating. Testing conducted in accordance with ISO 11979-3 demonstrated that the Aero Z Cartridge IOL Delivery System can deliver IOL Models EC-3 and EC-3 PAL without significantly impacting the optical or mechanical performance, dimensions or the cosmetic appearance of the lens.
Based on the indications for use and the technological characteristics, it can be concluded that the Aero Z Cartridge IOL Delivery System is substantially equivalent to the predicate device.
Substantial Equivalence 5.8
On the basis of the same indications for use, materials and mechanism of action, the Aero Z Cartridge IOL Delivery System is substantially equivalent to the predicate device (Monarch III IOL Delivery System, C Cartridge).
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/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 tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.
Public Health Service
April 15, 2013
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Aaren Scientific, Inc. % Mr. Robert Sheehan . Vice President of Regulatory Affairs and Quality Systems 4290 East Brickell Street, Bldg A Ontario, CA 91761-1569
Re: K123888
Trade/Device Name: AERO™ Z Cartridge IOL Delivery System Regulation Number: 21 CFR 886.4300 Regulation Name: Intraocular lens guide Regulatory Class: Class I (reserved) Product Code: MSS Dated: March 7, 2013 Received: March 11, 2013
Dear Mr. Sheehan:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
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
5
Page 2 - Mr. Robert Sheehan
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 (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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/MedicalDevices/Safety/ReportaProblem/default.htm 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Kesia YAlexander -S
for 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 -
6
Aero Z Cartridge IOL Delivery System Device Name:
Indications for Use:
The Aero Z Cartridge IOL Delivery System is indicated to fold and insert Aaren Scientific IOLs that have the use of this inserter in their approved labeling.
Prescription Use X AND/OR (21 CFR 801 Subpart D)
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)
Tieuvi Hī 2013.04.05 1:5 5:07 -04'00'
(Division Sign-Off) Division of Ophthalmic and Ear, Nose and Throat Devices
510(k) Number: K123888