(7 days)
The MediSISS™ Reprocessed Phacoemulsification Tips/Needles are intended to emulsify and excise cataract tissue in ophthalmic microsurgical procedures.
Reprocessed Phacoemulsification Tips/Needles are specifically designed to be used to emulcataractous lens material and remove it from the eye (phacoemulsification). Electric energy is generated in the Phacoemulsification System, delivered in a headpiece, and is finally converted to ultrasonic energy delivered through a hollow titanium needle or tip. Irrigation fluid is delivered to the eye via a combination of an irrigation sleeve over the handpiece tip. The emulsified lens material is aspirated out of the eye through the center of the headpiece /tip assembly. The headpieces are routinely used repeatedly in multiple surgical procedures, while the tips are marketed as single use only.
The provided text is a 510(k) clearance letter from the FDA regarding a reprocessed medical device, specifically MediSISS™ Reprocessed Phacoemulsification Tips/Needles. It does not describe an AI medical device or its performance criteria. Therefore, most of the requested information regarding AI device acceptance criteria, studies, sample sizes, expert involvement, and ground truth establishment is not applicable to this document.
However, based on the provided text, I can extract the following relevant details about the reprocessed medical device itself:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly present a table of numerical acceptance criteria for a new AI device or its performance. Instead, it focuses on demonstrating that the reprocessed devices are substantially equivalent to legally marketed predicate devices and meet certain established standards for reprocessing.
| Acceptance Criterion Type | Details from Document (for reprocessed device) |
|---|---|
| Functional Design | Identical to predicate devices |
| Materials | Identical to predicate devices |
| Indications for Use | Identical to predicate devices |
| Methods of Construction | Similar to predicate devices |
| Cleaning Validation | Complies with AAMI RDS0TIR No. 12-1994 and FDA Reviewer Guidance for "Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities." |
| Sterilization Validation | Complies with ANSI/AAMI/ISO 11135-1994 (Ethylene Oxide Sterilization) |
| EO Residuals | Complies with ANSI/AAMI/ISO 10993-7:1995 (Biological Evaluation of Medical Devices - Ethylene oxide sterilization residual). |
| Mechanical Testing | Devices undergo mechanical testing to demonstrate that parts do not change in function. |
| Visual Testing | 100% visual inspection of all products prior to packaging, labeling, and sterilization. |
Study that Proves the Device Meets Acceptance Criteria:
The "study" described in the document is a validation submission for reprocessed single-use devices. It demonstrates substantial equivalence.
- Cleaning, sterilization, packaging validations, and visual/mechanical testing were performed to show that the reprocessed devices are equivalent to new devices and are safe and effective for their intended use.
- Process validation testing was specifically done to validate the cleaning and sterilization procedures, as well as the device's packaging.
- The conclusion states that the device meets the requirements of the stated standards and embodies technological characteristics identical to the predicate device, implying it is safe, effective, and performs as well as or better than the predicate device.
Information Not Applicable or Available from the Provided Text (for an AI device):
The following points are not directly addressed as the document concerns a reprocessed physical medical device, not an AI medical device:
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for a reprocessed physical device. Validation involves testing of the reprocessed devices themselves, not a data set.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. Ground truth for a reprocessed device would involve analytical and performance testing against established standards, not expert consensus on data interpretation.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is not an AI device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for this reprocessed device centers on compliance with established reprocessing standards (cleaning, sterilization, material integrity, functional performance) and substantial equivalence to the original predicate devices. This is verified through laboratory testing and engineering analysis rather than clinical outcomes data or expert consensus on diagnostic interpretations.
- The sample size for the training set: Not applicable, as this is not an AI device.
- How the ground truth for the training set was established: Not applicable, as this is not an AI device.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of human profiles facing right, stacked on top of each other. The profiles are rendered in black and have a flowing, abstract design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the graphic.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 2004
MediSISS™, Inc. c/o Ms. Brandi James Regulatory Specialist 2747 SW 6th Street Redmond, OR 97756
Re: K030179 - Supplemental Validation Submission Trade/Device Name: See Enclosed List Regulation Number: 21 CFR 886.4670 Regulation Name: Phacofragmentation System Regulatory Class: Class II Product Code: 86 NKX Dated: January 15, 2003 Received: January 17, 2003
Dear Ms. James:
The above-referenced premarket notification (510(k)) was cleared by the Office of Device Evaluation (ODE) on January 24, 2003. We have received your supplemental validation data as required for reprocessed single-use devices by the Medical Device User Fee and Modernization Act of 2002. After reviewing your supplemental validation data, we have determined the devices listed in the enclosure accompanying this letter are 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 these devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (PMA) they 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 devices in the Federal Register.
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Page 2- Ms. Brandi James
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your devices comply 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 applicable 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.
The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in classification for your devices and thus, permits you to legally market the devices. This letter will allow you to continue marketing the devices listed in the enclosure accompanying this letter.
If you desire specific advice for your devices 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
David Dr. Wajsble
A. Ralph Rosenthal, M.D.
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure - Attachment 1 - List of Catalog Model Numbers
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ATTACHMENT 1
ALCON Laboratories, Inc.'s Series 20000™ Legacy® Phacoemulsification Tips Catalog Model Numbers To Be Reprocessed By MediSISS, Inc.
| 30RTS | 0.9mm, MicroTip™, Purple | 30° Round |
|---|---|---|
| 45RTS | 0.9mm, MicroTip™, Purple | 45° Round |
| 30KTS | 0.9mm, MicroTip™, Purple | 30° Kelman® |
| 45KTS | 0.9mm, MicroTip™, Purple | 45° Kelman® |
| 8065790019 | 0.9mm, ABS™ MicroTip™, Purple | 0° Round |
| 8065790020 | 0.9mm, ABS™ MicroTip™, Purple | 30° Round |
| 8065790021 | 0.9mm, ABS™ MicroTip™, Purple | 45° Round |
| 8065790022 | 0.9mm, ABS™ MicroTip™, Purple | 30° Kelman® |
| 8065790023 | 0.9mm, ABS™ MicroTip™, Purple | 45° Kelman® |
| 8065740836 | 0.9mm, ABS™ MicroTip™, Purple | 0° Round, Flared |
| 8065740837 | 0.9mm, ABS™ MicroTip™, Purple | 30° Round, Flared |
| 8065740838 | 0.9mm, ABS™ MicroTip™, Purple | 45° Round, Flared |
| 8065740839 | 0.9mm, ABS™ MicroTip™, Purple | 30° Kelman®, Flared |
| 8065740840 | 0.9mm, ABS™ MicroTip™, Purple | 45° Kelman®, Flared |
| 15RT | 1.1mm, TurboSONICS® Standard U/S Tip, Blue | 15° Round |
| 30RT | 1.1mm, TurboSONICS® Standard U/S Tip, Blue | 30° Round |
| 45RT | 1.1mm, TurboSONICS® Standard U/S Tip, Blue | 45° Round |
| 30KT | 1.1mm, TurboSONICS® Standard U/S Tip, Blue | 30° Kelman® |
| 45KT | 1.1mm, TurboSONICS® Standard U/S Tip, Blue | 45° Kelman® |
| 8065740791 | 1.1mm, TurboSONICS® Standard ABS™ Tip, Blue | 0° Round |
| 8065740792 | 1.1mm, TurboSONICS® Standard ABS™ Tip, Blue | 30° Round |
| 8065740793 | 1.1mm, TurboSONICS® Standard ABS™ Tip, Blue | 45° Round |
| 8065740794 | 1.1mm, TurboSONICS® Standard ABS™ Tip, Blue | 30° Kelman® |
| 8065740795 | 1.1mm, TurboSONICS® Standard ABS™ Tip, Blue | 45° Kelman® |
| 8065740805 | 1.1mm, TurboSONICS® Standard ABS™ Tip, Blue | 0° Round, Flared |
| 8065740806 | 1.1mm, TurboSONICS® Standard ABS™ Tip, Blue | 30° Round, Flared |
| 8065740807 | 1.1mm, TurboSONICS® Standard ABS™ Tip, Blue | 45° Round, Flared |
| 8065740808 | 1.1mm, TurboSONICS® Standard ABS™ Tip, Blue | 30° Kelman®, Flared |
| 8065740809 | 1.1mm, TurboSONICS® Standard ABS™ Tip, Blue | 45° Kelman®, Flared |
..............................................................................................................................................................................
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Tichesticons Tor USS
Page 1 of 1
510(k) Number (if known): K030179
Device Name: MediSISS™ Reprocessed Phacoemulsification Tips/Needles
Indications for Use:
ﻣﻠﻔﺎﺕ ﺩﺭ
The MediSISS™ Reprocessed Phacoemulsification Tips/Needles are intended to emulsify and excise cataract tissue in ophthalmic microsurgical procedures.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Treuth Been
(Division Sign-Off)
Over-The-Counter Use
(Optional Format 1-2-96)
MediSISS™
723 Curtis Court, Sisters, OR 97759
December 27th, 200
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K030179 Page 34 of 36
submitted by
JAN 2 4 2003
MediSISS, Inc. P.O. 2060 723 Curtis Court Sisters, OR 97759 Phone: (800)-860-9482 Fax: (541) 549-4527 Email: mabarker(@medisissinc.com
| Contact Person: | Mary Ann Barker |
|---|---|
| Device Trade Names: | MediSISS TM Reprocessed Phacoemulsification Tips/Needles |
| Common Names: | Reprocessed Phacoemulsification Tips/Needles |
| Classification Names: | Ophthalmic Devices, Phacofragmentation Needle, Electric, per21 CFR §886.4670; Product Code: HQC; Regulatory Class: II |
Identification of a Legally Marketed Predicate Device
The MediSISS™ Reprocessed Phacoemulsification Tips/Needles are substantially equivalent to the Phacoemulsification Tips/Needles as listed below:
Company
510(k) #
| Alcon | K981103, K861380, K832836, K902798, |
|---|---|
| K911808, K980292 |
They are also similar to the reprocessed hot biopsy forceps reprocessed by Alliance Corporation and legally marketed and distributed pursuant to Reprocessed Phacoemulsification Tips 510(k) K012637. Likewise, SterilMed, Inc. Reprocessed Phaco Tips: - 510(k) K012579; and Vanguard Medical Concepts, Inc Vanguard Reprocessed Phacoemulsification Needles/Tips, 510(k) K0126098
Device Description
Reprocessed Phacoemulsification Tips/Needles are specifically designed to be used to emulcataractous lens material and remove it from the eye (phacoemulsification). Electric energy is generated in the Phacoemulsification System, delivered in a headpiece, and is finally converted to ultrasonic energy delivered through a hollow titanium needle or tip.
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Irrigation fluid is delivered to the eye via a combination of an irrigation sleeve over the handpiece tip. The emulsified lens material is aspirated out of the eye through the center of the headpiece /tip assembly. The headpieces are routinely used repeatedly in multiple surgical procedures, while the tips are marketed as single use only. However, devices that the OEM has listed as predicates on their 510(k) i.e.: K981103, are reusable. Also, according to Alcons 510(k) K981103, the OEM took a single-use device and resubmitted it to clear for multiple reprocessing (usage up to 20 surgical procedures). This 510(k) was cleared to market on 6/23/98.
Intended Use
The MediSISS™ Reprocessed Phacoemulsification Tips are designed to emulsify and excise cataract tissue in ophthalmic microsurgical procedures.
Summary of Technological Characteristics
The intended use and technological features of the reprocessed devices do not differ from the legally marketed predicate device(s). Both the reprocessed devices(s) and the predicate device(s) have the same materials and product design. There are no changes to the claims, intended use, clinical applications, patient populations, performance specifications, or methods of operation. The technological characteristics of the reprocessed phacoemulsification tips/needles are the same as those of the legally marketed predicate devices. The technological characteristics of the reprocessed phacoemulsification tips/needles are the same as those of the legally marketed predicate devices. In addition the MediSISS™ manufacturing process includes 100 % visual and mechanical testing of all products prior to packaging, labeling, and sterilization.
Summary of Performance Data
The MediSISS™ Reprocessed Phacoemulsification Tips/Needles comply with the following standards, practices, and guidance's:
Sterilization Validation and EO Residuals:
- ANSI/AAMI/ISO 11135-1994, Medical Devices----Validation and Routine Control of . Ethylene Oxide Sterilization
- ANSI/AAMI/ISO 10993-7:1995, Biological Evaluation of Medical Devices-Part 7: . Ethylene oxide sterilization residual.
Cleaning Validation:
- AAMI RDS0TIR No. 12-1994. Designing, Testing, and Labeling Reusable Medical . Devices for Reprocessing in Health Care Facilities: A guide for Device Manufactures. Association for the Advancement of Medical Instrumentation, Arlington, VA.Food and Drug Administration, 1996.
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- Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: FDA . Reviewer Guidance, Office of Device Evaluation. FDA, Washington, D.C.
Cleaning, sterilization, packaging validations, and visual/mechanical testing demonstrate that the devices are equivalent and continue to be safe and effective for their intended use.
MediSISS™ Reprocessed Phacoemulsification Tips/Needles undergo mechanical testing to demonstrate that the parts do not change in function. Process validation testing was done to validate the cleaning and sterilization procedures as well as the device's packaging.
Conclusion
Since the MediSISS™ Reprocessed Phacoemulsification Tips/Needles meet the requirements of the stated standards and embody technological characteristics identical to the predicate device, we believe the device is safe and effective and performs as well as or better than the predicate device. The MediSISS™ Reprocessed Phacoemulsification Tips/Needles will be reprocessed per specifications and good manufacturing practices that ensure the device is safe and effective for its intended use.
In Accordance with the Federal Food, Drug, and cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification, MediSISS™ concludes that the device(s)(Reprocessed Phacoemulsification Tips/Needles) are safe, effectives, and substantially equivalent to the predicate devices as described herein.
This conclusion is based upon the devices' similarities in functional design, materials, indications for use, and methods of construction.
§ 886.4670 Phacofragmentation system.
(a)
Identification. A phacofragmentation system is an AC-powered device with a fragmenting needle intended for use in cataract surgery to disrupt a cataract with ultrasound and extract the cataract.(b)
Classification. Class II.