This device is intended for use during procedures when a wound or surgical site must be cleared by non-contact means for improved visibility at the site.

Device Description

The ClearView Blower/Mister includes a hand grip with a 3 1/4" or 6 1/2" malleable stainless steel shaft for ease of positioning the device near the surgical site. The soft, silicone tip contains a plastic tube which carries saline to the tip. The proximal end includes a fluid inlet line which terminates in a locking female luer for connection to the fluid administration set. The gas line, located on the proximal end, has an in-line 0.2 micron filter and terminates in a slip connector for connection to the gas source tubing.

AI/ML Overview

Here's an analysis of the provided text, focusing on acceptance criteria and the study demonstrating that the ClearView Blower/Mister meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Predicate Performance	ClearView Blower/Mister Performance	Conclusion
Force Exerted by Gas/Saline Stream	Consistent force over range of discharge heights for a given flow rate	Not explicitly stated, but predicate exerted 70% more force at max flow/min discharge.	Consistent over tested flow and discharge height conditions.	Met (consistent force for ClearView)
Magnitude of Force (Comparative)	Force exerted by gas/saline stream at labeled maximum flow rates and max/min discharge heights should be comparable to predicate.	Approximately 70% greater than ClearView at maximum flow and minimum discharge height.	Exerted less force (by ~70%) than the predicate at maximum flow and minimum discharge height.	Met (considered acceptable given the "comparable" implication rather than exact match)
**Mist Pattern	Shape and Center**	Circular shape, centered under the discharge tip (implied ideal for surgical visibility).	Oval shape, major axis perpendicular to discharge tip.	Circular shape, centered under the discharge tip.
**Effect of Repeated Bends on Malleable Shaft	Air Flow Rate**	No measurable change in air flow rate after repeated/multiple bends.	Not applicable (ClearView specific test).	No measurable changes in air flow rate observed.
**Effect of Repeated Bends on Malleable Shaft	Saline Flow Rate**	No measurable change in saline flow rate after repeated/multiple bends.	Not applicable (ClearView specific test).	No measurable changes in saline flow rate observed.

2. Sample Size Used for the Test Set and Data Provenance

The document does not provide specific sample sizes (e.g., number of devices tested, number of repetitions for each test) for the non-clinical performance data. It describes the tests conducted on "this device" (ClearView Blower/Mister) and "the predicate device."

The data provenance is not explicitly stated. Given it's a 510(k) submission, it's highly likely to be internal company testing (Medtronic/DLP) conducted in a controlled laboratory environment. The testing is prospective in the sense that the experiments were designed and executed to evaluate the new device against its predicate and established criteria.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This information is not applicable to this submission. The tests performed are non-clinical, measuring physical characteristics and performance of the device (force, mist pattern, flow rates). Ground truth was established through direct physical measurement using scientific instrumentation, not through expert consensus or clinical evaluation.

4. Adjudication Method for the Test Set

This information is not applicable. Since the tests are objective physical measurements, there's no need for an adjudication method as would be used for subjective assessments or image interpretation.

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

There was no MRMC comparative effectiveness study conducted. This is a non-clinical evaluation of a surgical device, not an AI or imaging diagnostic tool.

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

This is not applicable. The device is a physical surgical instrument, not an algorithm.

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

The ground truth for the non-clinical performance tests was based on objective physical measurements using instruments and controlled experimental setups. This includes:

Measurement of force exerted by the gas/saline stream.
Visual/instrumental assessment of mist pattern shape and centering.
Measurement of air and saline flow rates.

8. The sample size for the training set

This information is not applicable. There is no "training set" as this is not a machine learning or AI-based device.

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

This information is not applicable. As stated above, there is no training set. The "ground truth" for the performance evaluation was established through direct physical measurements of the device's characteristics.

Summary

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Medironic &

K 7/57-2

DEC - 8 1997

x: (616) 242-5262

510(k) SUMMARY

PROPRIETARY NAME: ClearView Blower/Mister COMMON NAME: Lavage or irrigation device CLASSIFICATION NAME: Jet lavage per 21 CFR 880.5475

LEGALLY MARKETED PREDICATE DEVICE

The claim of substantial equivalence of the ClearView Blower/Mister is made to the RMI VisuFlow Surgical Site Visualization Wand, K922083.

DEVICE DESCRIPTION

INTENDED USE

This device is intended for use during procedures when a wound or surgical site must be cleared by non-contact means for improved visibility at the site.

TECHNOLOGICAL CHARACTERISTICS

Both devices clear the surgical site using a pressurized stream of filtered USP medical air and a saline mist. The gas line in both devices includes a 0.2 micron hydrophobic filter. Both RMI and DLP devices require a 8' PVC gas line and standard IV administration set for delivering air and saline to the device. With both products, the mist is controlled by adjusting the saline using the roller clamp and/or the air using the regulated gas flow control. Both devices are sterile, non-pyrogenic and single use only.

NON-CLINICAL PERFORMANCE DATA

This device was tested to determine the force exerted by the gas/saline stream under various flow rates at varying distances from a flat surface. The force was consistent over the range of discharge heights for a given flow rate. Both models performed consistently over the tested flow and discharge height conditions.

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This device and the predicate device were tested to determine the force exerted by the gas/saline stream at the labeled maximum flow rates at the labeled maximum and minimum discharge heights. The predicate device exerted a force approximately 70% greater at maximum flow and minimum discharge height conditions.

The mist pattern delivered by this device and the predicate device were measured under typical air flow rates over the recommended range of saline flow rates and discharge heights. The mist pattern of this device was circular in shape and centered under the discharge tip. The mist pattern of the predicate device is oval in shape with the major axis perpendicular to the discharge tip.

This device was tested to determine the effect that repeated/multiple bends of the malleable shaft have on the performance of the product under fixed flow conditions. No measurable changes in air or saline flow rates were observed.

SUBSTANTIAL EQUIVALENCE CONCLUSION

The performance testing results demonstrate the ClearView Blower/Mister is substantially equivalent to the RMI Surgical Site Visualization Wand.

Gretchen Hartlage September 12, 1997

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's commitment to health, human services, and well-being. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 8 1997

Ms. Gretchen Hartlage Senior Product Regulation Manager DLP, Division of Medtronic, Incorporated 620 Watson, S.W. 49501-0409 Grands Rapids, Michigan

K973485 Re: ClearView Blower/Mister Trade Name: Requlatory Class: II Product Code: FQH Dated: September 12, 1997 September 15, 1997 Received:

Dear Ms. Hartlage:

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 The general controls provisions of the Act of the Act. include requirements for annual reqistration, 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 requlation (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 In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obliqation you miqht have under sections 531

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Page 2 - Ms. Hartlage

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 device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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,

Timb ny A. Ulatowsk Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K973485

510(k) Number (if known):

Device Name:____ClearView Blower/Mister

Indications For Use:

This device is intended for use during procedures when a wound or surgical site must be cleared by non-contact means for improved visibility at the site.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Paltarer Casanati

(Division St. Division of D and GE 510(k) Number

escription Use
(Per 21 CFR 801.109)

Over-The-Counter Use_

Regulation Number and Section

§ 880.5475 Jet lavage.

(a)
Identification. A jet lavage is a device used to clean a wound by a pulsatile jet of sterile fluid. The device consists of the pulsing head, tubing to connect to a container of sterile fluid, and a means of propelling the fluid through the tubing, such as an electric roller pump.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.