ENT IRRIGATING PUMP (70327700) by GYRUS ENT L.L.C.

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.

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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "ENTire™ Irrigating Pump." This document focuses on demonstrating substantial equivalence to existing predicate devices rather than proving performance against specific acceptance criteria through a clinical study.

Therefore, many of the requested details about acceptance criteria, study design, and ground truth establishment are not applicable to this type of regulatory submission. The 510(k) process for a device like this, particularly in 1997, relied heavily on showing that the new device is as safe and effective as a legally marketed predicate device.

Here's an analysis based on the provided text, addressing the points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: The primary "acceptance criteria" for a 510(k) submission are that the device is substantially equivalent to a predicate device in terms of intended use, technological characteristics, and safety/effectiveness. This is a regulatory standard, not a performance metric like sensitivity or specificity.
Reported Device Performance: The document states that the ENTire Irrigating Pump is substantially equivalent to three predicate devices: the Essential Shaver System, the XPS Irrigator Pump, and the Endo-Scrub Lens Cleaning System. It also claims:
- "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."
- "Differences between the ENTire Irrigating Pump and the predicate devices should not affect the safety or effectiveness."
- The device is designed to meet UL 2601-1-2 and CSA 22.2 No. 601-1 (safety standards for medical electrical equipment).

The table below reflects this understanding:

Acceptance Criteria (Demonstrated through Substantial Equivalence)	Reported Device Performance (Claimed Equivalence/Compliance)
Intended Use Equivalence	"Intended use... are substantially equivalent."
Technological Characteristics Equivalence	"Power modality... and the mode of operation are substantially equivalent.""The power instrumentation technology utilized in the system is equivalent to existing marketed devices."
Safety and Effectiveness Equivalence	"Differences... should not affect the safety or effectiveness."
Compliance with Recognized Standards	Designed to meet UL 2601-1-2 and CSA 22.2 No. 601-1

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. This submission does not describe a clinical performance study with a test set in the conventional sense (e.g., patient data for an algorithm). The "testing" involved demonstrating compliance with general safety standards (UL, CSA) and comparing technical specifications to predicate devices.

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. No ground truth in the context of expert review of performance data was established for a test set. Substantial equivalence relies on regulatory review of technical documentation and comparison to predicate devices, not expert consensus on diagnostic or treatment outcomes of the new device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. No test set or expert adjudication related to performance was conducted or 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. This device is an irrigating pump, not an AI or diagnostic imaging device. An MRMC study is not relevant to its regulatory pathway or function.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is a mechanical pump, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not applicable. The "ground truth" for this 510(k) submission is the pre-existing regulatory classification and safety/effectiveness history of the predicate devices, alongside the technical specifications and safety standard compliance of the new device.

8. The sample size for the training set:

Not applicable. There is no "training set" as this is not an AI/machine learning product.

9. How the ground truth for the training set was established:

Not applicable. As above, no training set or ground truth in that context was established.

In summary, the provided document is a 510(k) premarket notification that demonstrates substantial equivalence for a medical device (an irrigating pump) by comparing it to already legally marketed predicate devices and affirming compliance with relevant safety standards. It does not contain information about clinical performance studies, test sets, expert reviews, or AI-related metrics as would be found for more complex diagnostic or algorithmic devices.

Summary

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Food and Drug Administration 510(k) Notification - Entire Irrigating Pump August 29, 1997

K973286

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 PumpAccessory to the Ear, Nose and Throat ElectricSurgical Drill
Classification Name:	Ear, nose and throat electric or pneumatic surgical drill(§ 874.4250)
Official Contact:	Deborah ArthurGroup ManagerRegulatory & Quality AssuranceSmith & Nephew, INC.ENT Division2925 Appling RoadBartlett, 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.

Differences between the ENTire Irrigating Pump and the predicate devices should not affect the safety or effectiveness.

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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

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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:

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)

Regulation Number and Section

§ 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.