The XPS Tissue Aspiration System remains essentially the same as originally described in K963246. There is a Power Control Unit, a footswitch, reusable handpiece and various interchangeable, disposable cannulas. Suction is provided by either standard hospital wall vacuum or a commercially available medical aspirator.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Xomed XPS Tissue Aspiration System. The focus of the submission is to demonstrate substantial equivalence to predicate devices, rather than a detailed study proving the device meets specific acceptance criteria in the manner of a clinical trial for a new drug or novel medical device. Therefore, much of the requested information (e.g., sample size for test sets, ground truth methodology, MRMC studies) is not present in this document.

The "study" described here is primarily a bench-top comparison against predicate devices and an assessment of technological differences.

Here's an analysis based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly those required to demonstrate "substantial equivalence" to predicate devices as defined by the FDA's 510(k) process. This means showing that the device is as safe and effective as a legally marketed device and does not raise new safety or effectiveness concerns.

Acceptance Criteria (Implicit)	Reported Device Performance and Evidence
Aspiration and Penetration Functionality (for tissue and fluids)	"Laboratory testing demonstrates that the proposed XPS System will aspirate and penetrate tissue the same as the predicate suction cannulas."
General Surgical Procedures Indication (removal of tissue and fluids)	The XPS System's intended use ("for the removal of tissue and fluids from the body during general surgical procedures") is stated to be "equivalent to the current intended use of the XPS System, is the same as the predicate devices." The predicates were also cleared for general surgical procedures.
Technological Differences Not Raising New Safety/Effectiveness Concerns (e.g., morcellation mechanism vs. reciprocation)	"The only difference is that the cannula has an internal rotating cannula to morcelize the tissue into smaller pieces... making aspiration easier and to help prevent clogging.""Although their dynamics are different [XPS rotary vs. PAD reciprocating], they are both intended to assist in the tissue removal process.""...the minor technological differences compared to the predicate devices raise no new issues of safety or effectiveness."

Note: The document does not provide specific quantitative acceptance criteria (e.g., minimum aspiration rate, maximum clogging frequency) or numerical results from the laboratory testing.

Study Details

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified. The document refers to "Laboratory testing," but doesn't detail the number of samples, types of tissue, or duration of tests.
- Data Provenance: The testing appears to be internal "Laboratory testing" conducted by Xomed Surgical Products. There is no mention of country of origin of data or whether it was retrospective or prospective in a clinical sense. This would typically be bench-top testing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The document describes engineering/bench testing rather than a study requiring expert-established ground truth in a diagnostic context. The "ground truth" for function would be direct observation and measurement of aspiration and penetration capabilities.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. There is no mention of human adjudication for data interpretation in this context.
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 is not an AI-powered diagnostic device, and thus no MRMC study or AI-assisted improvement study was conducted or is relevant to this submission.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable, as this is not an AI algorithm. The device performance (aspiration and penetration) is evaluated as a standalone product through "laboratory testing."
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the laboratory testing would likely be direct experimental measurement and observation of the device's functional performance (e.g., volume of fluid aspirated, depth of penetration into a tissue simulant, ability to morcellate tissue). It is not based on expert consensus, pathology, or clinical outcomes data in this context.
The sample size for the training set:
- Not applicable. As this is not a machine learning device, there is no "training set."
How the ground truth for the training set was established:
- Not applicable, as there is no "training set."

Summary

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K984363

510(k) Summary

1.0 Date Prepared December 4, 1998
2.0 Submitter (Contact) David Timlin Xomed Surgical Products Jacksonville, FL (904) 279-7532

3.0 Device Name

Proprietary Name:	XPS Tissue Aspiration SystemXPS StraightShot or Model 2000 Microdebrider System(The proposed product tradename has not been finalizedand may be changed at a later date)
Common Name(s):	Surgical Aspiration System
Classification Name:	Surgical instrument, AC powered motors andaccessories / attachmentsManual or powered portable aspiration pump

5.0 Device Classification

Surgical instrument, AC powered motors and accessories / attachments 21 CFR 878.4820 Exempt from 510k Procode 79GEY Class | :

Manual or powered portable aspiration pump 21 CFR 878.4780 Tier ? Procode 79BTA Class II ;

6.0 Device Description

7.0 Intended Use

The Xomed XPS Tissue Aspiration System is intended for the removal of tissue and fluids from the body during general surgical procedures.

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8.0 Substantial Equivalence

The XPS System, with expanded indications that include tissue and fluid removal in general surgical procedures, is substantially equivalent to the following predicate devices that have been cleared for general removal of fluid and loose tissue:

Powered Aspiration System MicroAire "Powered Aspiration Device" PAD-100 K973268 (MicroAire Surgical Instruments)

Aspiration Cannulas Various aspiration cannulas (Wells Johnson Company)

K832520

The predicate systems described above have also been cleared for the removal of tissue and fluids in general surgical procedures. Generally, all of these systems involve a handpiece with a hollow, stainless steel cannula with one or more openings at the tip. The cannula come in various lengths and diameters with a variety of tip configurations . Connected to an active power unit or suction source, tissue (and fluid ) is aspirated into the openings in the cannula tip while it is avulsed and suctioned off through the hollow shaft.

The XPS system is equivalent in that it also includes a handpiece with a cannula that is attached to a power unit. The only difference is that the cannula has an internal rotating cannula to morcelize the tissue into smaller pieces, making aspiration easier and to help prevent clogging. With continuous suction, the tissue is aspirated into the port or window in the outer cannula, morcelized by the rotary action of the inner cannula, and then easily suctioned upward through the shaft.

Like the XPS. the MicroAire "Powered Aspiration Device" PAD-100 (K973268) also uses powered cannulas to remove tissue and fluids. In contrast to the rotary action inside the XPS cannula. the entire PAD cannula rapidly reciprocates, simulating the back and forth manual motions of a surgeon. Although the reciprocating action is meant to facilitate the passage of the cannula through the tissue, the tissue is still rasped and torn to separate it for removal.

Laboratory testing demonstrates that the proposed XPS System will aspirate and penetrate tissue the same as the predicate suction cannulas. The use of a powered cannula is also not unique as demonstrated by the currently marketed MicroAire PAD. Although their dynamics are different, they are both intended to assist in the tissue removal process. The additional indication proposed for the XPS System, to remove tissue and fluid in general surgery, is equivalent to the current intended use of the XPS System, is the same as the predicate devices; and, the minor technological differences compared to the predicate devices raise no new issues of safety or effectiveness.

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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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines beneath them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 26 1999

Mr. David M. Timlin Manager. Regulatory Affairs XOMED, Inc. 6743 Southpoint Drive, North Jacksonville, Florida 32216-0980

Re: K984363 Trade Name: XPS Tissue Aspiration System Regulatory Class: II Product Code: BTA Dated: December 4, 1998 Received: December 7, 1998

Dear Mr. Timlin:

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 the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 -- Mr. David M. Timlin

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) 594-4595. 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,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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984363 510(k) Number (if known): __

Device Name: XPS Tissue Aspiration System

Indications for Use:

The Xomed XPS Tissue Aspiration System is intended for the removal of tissue and fluids from the body during general surgical procedures.

(Please do not write below this line - continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

Over-the-Counter Use
(Optional Format 1-2-96)

(Division Sign-Off)
Division of General Restorative Devices
510(K) Number K904363

Regulation Number and Section

§ 878.4780 Powered suction pump.

(a)
Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.(b)
Classification. Class II.