(11 days)
Not Found
No
The description focuses on a mechanical pump and sheath system for irrigation and cleaning, with no mention of AI, ML, image processing, or data-driven performance metrics.
No
The device is used to irrigate and clean the surgical site and endoscope lens during endoscopic sinus surgery. While it aids in the surgical procedure, it does not directly treat a disease or condition itself.
No
The device is described as a pump and sheath assembly for irrigation and cleaning during surgery, not for diagnosing conditions.
No
The device description explicitly states it is a "rotary peristaltic pump and sheath assembly," which are 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 for irrigating a surgical site and cleaning a sinuscope lens during endoscopic sinus surgery. This is a direct surgical intervention and cleaning process, not a diagnostic test performed on samples outside the body.
- Device Description: The device is a pump and sheath assembly used for irrigation and cleaning. This aligns with a surgical/procedural device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.) to provide diagnostic information about a patient's health status. IVDs are designed to detect, measure, or identify substances in these samples.
Therefore, the HydraClear System is a surgical accessory used during a procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The HydraClear System is intended for endoscopic sinus surgery, to irrigate the surgical site and to remove blood and tissue deposits from the surface of the sinuscope lens.
Product codes
EOB
Device Description
The HydraClear System is a rotary peristaltic pump and sheath assembly that provides both irrigation and cleaning.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
sinus
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 874.4760 Nasopharyngoscope (flexible or rigid) and accessories.
(a)
Identification. A nasopharyngoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the nasopharyngoscope and is intended to examine or treat the nasal cavity and nasal pharynx. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel and flexible plastic. This generic type of device includes the antroscope, nasopharyngolaryngoscope, nasosinuscope, nasoscope, postrhinoscope, rhinoscope, salpingoscope, flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biospy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.
0
Food and Drug Administration Special 510(k) - HydraClear System January 21, 1999
ENT Division Smith & Nephew. Inc 2925 Appling Rd., Bartlett, TN 38133 U.S. 901-373-0200, Toll Free: 1-800-262
Smith - Neph
FEB 2 1999
1
Exhibit H
510(k) Summary of Safety and Effectiveness
| Trade Name: | |
|---|---|
| -- | ------------- |
HydraClear™ Irrigating System Modification to the ENTire™ Irrigating Pump (K973286) and Accessories to Endoscope (K932988)
Common Name: Electrical Irrigating Pump and Accessories to Endoscopes
Classification Name: Nasopharyngoscope (flexible or rigid) and Accessories (21 CFR 874.4760)
- Official Contact: Jeff Cobb
Director R.A.\C.A.\Q.A. Smith & Nephew, INC. ENT Division 2925 Appling Road Bartlett, TN 38133
Telephone: (901) 373-0200
Telefax: (901) 373-0242
Date Prepared: January 21, 1999
The HydraClear System is substantially equivalent to the ENTire Irrigating Pump and the Suction/Irrigation Sheaths.
The HydraClear System is a rotary peristaltic pump and sheath assembly that provides both irrigation and cleaning.
The HydraClear Irrigating Pump's intended use is for providing both cleaning and irrigation during endosopic surgery to irrigate the surgical site and to remove blood and tissue deposits from the surface of the sinuscope lens.
1
The power instrumentation technology utilized in the system is equivalent to the ENTire Irrigating Pump. The HydraClear Irrigating Pump is designed to meet UL2601-1, CSA 22.2 No. 601-1, IEC 601-1, IEC 601-1, and IEC 601-1-2 requirements.
The HydraClear Sheaths, which meet the ISO 1099-1 requirements, are equivalent to the previously cleared Suction/Irrigation sheaths.
Differences between the HydraClear Irrigating Pump and Sheaths and the predicate devices should not affect the safety or effectiveness.
2
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 1999
Jeff Cobb Director, R.A.\C.A.\Q.A. Smith & Nephew, Inc. ENT Division 2925 Appling Road Bartlett, TN 38133
Re:
The HydraClear™ System Dated: January 21, 1999 Received: January 22, 1999 Regulatory class: II 21 CFR 874.4760/Procode: EOB
Dear Mr. Cobb:
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 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). 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 requlatory 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.
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 labeling requlation (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/dsma/dsmamain.html".
Sincerely yours,
Bert David C. Ostfeld, M.D.
Capt. Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Exhibit D
Indications for Use Statement
510(k) Number: HydraClear™ System Device Name
The HydraClear System is intended for endoscopic sinus surgery, to irrigate the Indications for The HydraClear System is intended for endostopic and tissue deposits from the surface Use of the sinusope lens.
Thind h. Segerson
(Division Sign-Off)
lvision of Reproductive, Abdominal, E and Radiological Do 510(k) Number
Prescription Use _ V (Per 21 CFR 801.109)