(71 days)
The Surge-free Aspiration Adapter is a filter protected flow restriction orifice used during cataract surgery to prevent/neutralize vacuum surges in the aspiration line.
The Surge-free Aspiration Adapter is a filter protected flow restriction device intended to be placed between the handpiece and aspiration tubing used during phacoemulsification surgery. The Surge-free Aspiration Adapter prevents/neutralizes vacuum surges in the aspiration line resulting from the sudden clearing of occlusions.
The provided text is a 510(k) premarket notification for a medical device called the "Surge-free Aspiration Adapter." This document focuses on demonstrating the substantial equivalence of the new device to existing legally marketed predicate devices, rather than detailed performance study results against specific acceptance criteria.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies cannot be fully extracted from the provided text. The document primarily describes the device, its intended use, and compares its technological characteristics to predicate devices. It does not contain information about a performance study with acceptance criteria.
However, I can provide the partially available information:
1. A table of acceptance criteria and the reported device performance
The document does not provide specific acceptance criteria or quantitative performance data. It describes the effect of the device: "Reduction in vacuum surges resulting from release of aspiration tubing occlusions."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not present in the document.
3. 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)
This information is not present in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not present in the document.
5. 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
This information is not present in the document. This device is not an AI-assisted diagnostic tool; it's a mechanical adapter for surgical equipment.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not present in the document. This device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not present in the document.
8. The sample size for the training set
This information is not present in the document.
9. How the ground truth for the training set was established
This information is not present in the document.
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STAAR Surgical Co. Surge-free Aspiration Adapter Premarket Notification
SECTION 15
SUMMARY OF SAFETY AND EFFECTIVENESS
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
Submitter's name, address, telephone number, contact person, and date 1. summary prepared;
- STAAR Surgical Company Submitter: a. 1911 Walker Ave. Monrovia, CA 91016 (626) 303 7902
- Herb Crane Contact Person: b.
- February ___ 2002 Date Summary C. Prepared:
Name of device, including trade name and classification name: 2.
- Surge-free Aspiration Adapter Trade/Proprietary Name: a. Classification Name: Unit, Phacofragmentation b.
Identification of the predicate device or legally marketed device or devices to 3. which substantial equivalence is being claimed:
| Product Name | Company Name | 510(k) # - Clearance Date |
|---|---|---|
| Vacuum SurgeSuppresser (VSS) | Surgin SurgicalInstrumentation | K950600 - 5/10/95 |
| PhacoGard | Syntec Inc. | K002932 - 1/4/01 |
| Automated ChamberMaintenance (ACM)Module | Paradigm Medical | K971795 - 7/14/97 |
Predicate Device Identification Table
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Description of Device: 4.
The Surge-free Aspiration Adapter is a filter protected flow restriction device intended to be placed between the handpiece and aspiration tubing used during phacoemulsification surgery. The Surge-free Aspiration Adapter prevents/neutralizes vacuum surges in the aspiration line resulting from the sudden clearing of occlusions.
Statement of intended use: 5.
The Surge-free Aspiration Adapter is a filter protected flow restriction orifice used during cataract surgery to prevent/neutralize vacuum surges in the aspiration line
Summary of technological characteristics compared to predicate devices: 6.
The table below illustrates how the technological characteristics of the Surge-free Aspiration Adapter compares to the predicate device.
| Characteristic | Surge-free Aspiration Adapter | Vacuum Surge Suppresser(VSS)K950600 |
|---|---|---|
| Placement | In aspiration line adjacent tohandpiece | In aspiration line adjacent tohandpiece |
| Materials | Silicone/Teflon | Silicone/Teflon |
| Sterilization | Steam | Gamma/Steam |
| Effect of device | Reduction in vacuum surges resulting from release of aspiration tubing occlusions | Reduction in vacuum surges resulting from release of aspiration tubing occlusions |
| Mode ofOperation | Vacuum surges are minimized by use of a restrictive bore connector. The restrictive bore is protected from occlusion itself by a Teflon mesh. | Vacuum surges are minimized by use of a collapsible chamber connecting two tubing sections. |
| Single Use orReusable | Single Use | Single Use and Reusable |
Technological Characteristic Comparison Table
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines beneath them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 6 2002
Mr. Herb Cane Director RA STAAR Surgical Co. 1911 Walker Ave. Monrovia, CA 91016
Re: K020734
Trade/Device Name: Surge-free Aspiration Adapter Regulation Number: 21 CFR 886.4670 Regulation Name: Phacofragmentation system Regulatory Class: II Product Code: HQC Dated: March 4, 2002 Received: March 6, 2002
Dear Mr. Cane:
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.
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.
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Page 2 - Mr. Herb Cane
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 and additionally 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
A. Ralph Rosenthal
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
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STAAR Surgical Co. Surge-free Aspiration Adapter
SECTION 6
INDICATIONS FOR USE
The Surge-free Aspiration Adapter is a filter protected flow restriction orifice used during cataract surgery to prevent/neutralize vacuum surges in the aspiration line.
Daryl L. Kausman
(Division Sign-Off) Division of Ophthalmic Ear, Nose and Throat Devises
510(k) Number ko 2 0 7 3 Y
长020734 Prescription Use (Per 21 CFR 801.109)
§ 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.