(27 days)
Not Found
Not Found
No
The summary describes a simple irrigating pump accessory and makes no mention of AI or ML capabilities.
No.
The device's intended use is to provide irrigant for cleansing and irrigation during surgical procedures, not to treat a specific disease or condition directly.
No
The device is described as providing irrigant during surgical procedures and cleansing the lens of an endoscope, which are functions related to surgical assistance and not diagnosis.
No
The device description explicitly states it is an "Irrigating Pump" and is designed to meet electrical safety standards (UL 2601-1-2 and CSA 22.2 No. 601-1), indicating it is a hardware device that provides irrigant.
Based on the provided information, the ENTire Irrigating Pump is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- ENTire Irrigating Pump Function: The ENTire Irrigating Pump's intended use is to provide irrigant during surgical procedures to cleanse the surgical site or the endoscope lens. It does not analyze biological samples or provide diagnostic information.
The device is used in vivo (within the body during surgery) and for procedural support, not for in vitro (outside the body) diagnostic testing.
N/A
Intended Use / Indications for Use
The ENTire Irrigating Pump is an accessory to the Smith & Nephew electrically powered surgical drill equipment as well as endoscopic visualization systems. It is intended to provide irrigant in conjunction with general ear, nose and throat/head & neck procedures.
This modification offers the surgeon the option of irrigating the surgical site or cleansing the lens of the endoscope during otolaryngologic/otoneurologic/head & neck/ endoscopic procedures.
Product codes (comma separated list FDA assigned to the subject device)
77 ERL, 77 EOB
Device Description
The ENTire Irrigating Pump is an accessory to the Smith & Nephew electrically powered surgical drill equipment as well as endoscopic visualization systems. It is intended to provide irrigant in conjunction with general ear, nose and throat/head & neck procedures. This modification offers the surgeon the option of irrigating the surgical site or cleansing the lens of the endoscope during otolaryngologic/otoneurologic/head & neck/ endoscopic procedures.
The power instrumentation technology utilized in the system is equivalent to existing marketed devices. Power modality, intended use, and the mode of operation are substantially equivalent. The ENTire Irrigating Pump is designed to meet UL 2601-1-2 and CSA 22.2 No. 601-1.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ear, nose and throat/head & neck
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon
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): 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.
The Essential Shaver System, the XPS Irrigator Pump, and the Endo-Scrub Lens Cleaning System
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
§ 874.4250 Ear, nose, and throat electric or pneumatic surgical drill.
(a)
Identification. An ear, nose, and throat electric or pneumatic surgical drill is a rotating drilling device, including the handpiece, that is intended to drive various accessories, such as an ear, nose, and throat bur (§ 874.4140), for the controlled incision or removal of bone in the ear, nose, and throat area.(b)
Classification. Class II.
0
Food and Drug Administration 510(k) Notification - Entire Irrigating Pump August 29, 1997
ENT Division
Smith & Nephew, Inc.
2925 Appling Rd., Bartlett, TN 38133 U.S.A.
901-373-0200, Toll Free: 1-800-262-3540, Fax: 901-373-0220
For orders and order inquiries: 1-800-238-7538
510(k) Summary of Safety and Effectiveness
| Trade Name: | ENTire™ Irrigating Pump |
|---|---|
| Common Name: | Electrical Irrigating Pump |
| Accessory to the Ear, Nose and Throat Electric | |
| Surgical Drill | |
| Classification Name: | Ear, nose and throat electric or pneumatic surgical drill |
| (§ 874.4250) | |
| Official Contact: | Deborah Arthur |
| Group Manager | |
| Regulatory & Quality Assurance | |
| Smith & Nephew, INC. | |
| ENT Division | |
| 2925 Appling Road | |
| Bartlett, TN 38133 | |
| Telephone: | (901) 373-0200 |
| Telefax: | (901) 373-0242 |
| Date Prepared: | August 29, 1997 |
SEP 29 1997The ENTire Irrigating Pump is substantially equivalent to the Essential Shaver System, the XPS Irrigator Pump and the Endo-Scrub Lens Cleaning System.
The ENTire Irrigating Pump is an accessory to the Smith & Nephew electrically powered surgical drill equipment as well as endoscopic visualization systems. It is intended to provide irrigant in conjunction with general ear, nose and throat/head & neck procedures. This modification offers the surgeon the option of irrigating the surgical site or cleansing the lens of the endoscope during otolaryngologic/otoneurologic/head & neck/ endoscopic procedures.
The power instrumentation technology utilized in the system is equivalent to existing marketed devices. Power modality, intended use, and the mode of operation are substantially equivalent. The ENTire Irrigating Pump is designed to meet UL 2601-1-2 and CSA 22.2 No. 601-1.
Differences between the ENTire Irrigating Pump and the predicate devices should not affect the safety or effectiveness.
1
Image /page/1/Picture/0 description: The image shows a logo that appears to be from a government agency. The logo features a stylized eagle or bird-like symbol with three curved lines representing its wings or feathers. The text "DEPARTMENT OF" is vertically oriented and positioned to the left of the bird symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Deborah A. Arthur Group Manager, Regulatory and Q. A. Smith and Nephew, Inc. ENT Division 2925 Appling Road Bartlett, TN 38133
Re: K973286
ENTire™ Irrigating Pump (ENT Electric or Pneumatic Drill and Nasopharyngoscope Accessory) Dated: August 29, 1997 Received: September 2, 1997 Regulatory Class: II SEP 2 9 1997 21 CFR 874.4250/Procode: 77 ERL 21 CFR 874.4760/Procode: 77 EOB
Dear Ms. Arthur:
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 requirement, 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 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 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 wititled, "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,
W.Liau Yin
Lillian Yin, Ph.D.
Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
2
Food and Drug Administration 510(k) Notification - Entire Irrigating Pump August 29, 1997
510(k) Number: Device Name: ENTire™ Irrigating Pump Accessory to the Ear, Nose and Throat Electrical Surgical Drill
Intended Use:
The ENTire Irrigating Pump is an accessory to the Smith & Nephew electrically powered surgical drill equipment as well as endoscopic visualization systems. It is intended to provide irrigant in conjunction with general ear, nose and throat/head & neck procedures.
This modification offers the surgeon the option of irrigating the surgical site or cleansing the lens of the endoscope during otolaryngologic/otoneurologic/head & neck/ endoscopic procedures.
David A. Seaman
(Division Sign-Off) Division of Reproductive, Abdominal, ENT. and Radiological Dev 510(k) Number .
Prescription Use
(Per 21 CFR 801.109)