(90 days)
This device is used by an ophthalmic surgeon to extend the irrigation/aspiration syringe by use of the tubing extension set away from the cannula allowing better control of irrigation/aspiration during the ophthalmic surgical procedure. This also allows the surgeons assistant to perform the irrigation/aspiration process if needed.
The Hurricane Medical tubing extension set consists of a length of silicone tubing with huer taper hubs (one male and one female) attached to both ends.
The provided text describes a medical device, the "Tubing Extension Set" by Hurricane Medical, and its regulatory clearance as substantially equivalent to existing devices. However, it does not include information about acceptance criteria or a study proving the device meets specific performance criteria in the way one would typically describe for a software-based medical device (e.g., an AI algorithm).
The document is a 510(k) premarket notification summary and an FDA clearance letter. It focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than presenting a detailed performance study with quantitative acceptance criteria for a novel device.
Therefore, for almost all the requested information, the answer will be "Not applicable" or "Information not provided in the given text."
Here's a breakdown of why based on your request:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitely stated as quantitative performance criteria. The submission focuses on demonstrating substantial equivalence to predicate devices for its intended use. | Device reported to be composed of "medical grade" silicone tubing meeting "USP class VI test for plastics." |
| Luer hub fittings have a "6% taper to assure proper fit to syringes and other medical devices." | |
| Sterilization process ensures "at least a 10⁻⁶ sterility assurance level (SAL)." | |
| The device "allows free movement of the aspiration/irrigation syringe" and "provides a greater level of control during aspiration/irrigation." (These are descriptive statements, not quantitative performance metrics). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable / Information not provided. This document does not describe a clinical or performance study with a "test set" in the context of an AI/algorithm-driven device. The "study" mentioned is a review of existing literature and the physical properties of the device components.
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)
- Not applicable / Information not provided. No "ground truth" was established by experts for a test set in the context of this 510(k) submission. Reference is made to historical uses described by "Emery et. al." and "Jaffe et. al." in ophthalmic surgery literature.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Information not provided. No test set or adjudication method is described.
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
- Not applicable / Information not provided. This device is a physical tubing extension set, not an AI algorithm. Therefore, an MRMC study related to AI assistance is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable / Information not provided. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable / Information not provided. The "truth" in this submission relies on established surgical practices using similar tubing, the physical and material properties of the tubing, and sterility validation for a physical product. Not a "ground truth" as typically defined for AI performance studies.
8. The sample size for the training set
- Not applicable / Information not provided. This is a physical medical device, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
- Not applicable / Information not provided. This is a physical medical device.
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Product Name: Tubing Extension Set Company: Hurricane Medical 2331K 63td Avenue East Bradenton, FL 34203 Phone Number: 941-751-8805 Contact Person: David A. Clapp
Device Classification Name: Replacement tubing for vitrectorny, 886,4150 Device Classification: 86MSR. Class II
Summary Of Safety And Effectiveness
Silicone tubing extension sets have been used for many vears in ophthalmic surgery as a means to deliver fluids to the surgical site and aspirate fluids away from the surgical site.
Emery et. al. describes the use of a length of silicone tubing for maintaining the anterior chamber pressure. The length of tubing is attached to a cannula at one end and an infusion bottle on the opposite end. Extracapsular Cataract Surgery, 1983, page 312.
Jaffe et. al. describe the use of a sterile extension set attached to a cystotome on one end and a syringe operated by an assistant at the other for fluid aspiration. Cataract Surgery, 1990, page 83.
The Hurricane Medical tubing extension set consists of a length of silicone tubing with huer taper hubs (one male and one female) attached to both ends.
This device is used by an ophthalmic surgeon to safely and effectively extend the irrigation/aspiration syringe by use of the tubing extension set away from the cannula or ophthalmic surgical instrument allowing better control of irrigation/aspiration during the ophthalmic surgical procedure. This also allows the surgeons assistant to perform the irrigation/aspiration process if needed.
The silicone tubing used is medical grade and meets the USP class VI test for plastics. The male and female luer hub fittings attached to the tubing ends contain a 6% taper to assure proper fit to syringes and other medical devices. The tubing extension set allows free movement of the aspiration/irrigation syringe during the procedure and provides a greater level of control during aspiration/irrigation. The devices are packaged in water impermeable and tear resistant Tyvek/Poly pouches that are heat sealed. The sterilization process ensures at least a 10° sterility assurance level (SAL).
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Image /page/1/Picture/1 description: The image is a black and white circular seal for the Department of Health & Human Services - USA. The seal features the department's logo, which consists of a stylized caduceus symbol with three lines representing the three branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN - 4 2000
Mr. David A. Clapp Hurricane Medical 2331K 63td Avenue East Bradenton, FL 34203
Re: K993361 Trade Name: Tubing Extension Set Regulatory Class: II Product Code: 86 MSR Regulation: 886.1450 (vitrectomy) Dated: October 1, 1999 Received: October 6, 1999
Dear Mr. Clapp:
` We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations .
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Page 2 - Mr. David A. Clapp
This letter will allow you to begin marketing your device as described in your 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
A. Ralph Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
' Enclosure
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Device Name: Tubing, Fluid Delivery
Indications for Use:
This device is used by an ophthalmic surgeon to extend the irrigation/aspiration syringe by use of the tubing extension set away from the cannula allowing better control of irrigation/aspiration during the ophthalmic surgical procedure. This also allows the surgeons assistant to perform the irrigation/aspiration process if needed.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
or
Prescription Use /
Over the -Counter Use_________________________________________________________________________________________________________________________________________________________
Eurette T. Boren
§ 886.4150 Vitreous aspiration and cutting instrument.
(a)
Identification. A vitreous aspiration and cutting instrument is an electrically powered device, which may use ultrasound, intended to remove vitreous matter from the vitreous cavity or remove a crystalline lens.(b)
Classification. Class II (special controls). The device, when it is phacofragmentation unit replacement tubing, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.