(150 days)
The XPS/PowerSculpt System with reciprocating adapter and suction cannula is indicated for the removal of soft tissue and fluid from the body during general surgical procedures including suction lipoplasty for aesthetic body contouring.
The Power Control Unit, handpiece and principle of operation remain essentially the same as described in K984363. The standard blades that are used for tissue debridement and aspiration will be replaced by suction cannulae equivalent in design to predicate suction lipoplasty cannulae. Lastly, a removable adapter, similar to the adapter cleared for rasping in K983025, will be provided to translate the rotary action of the handpiece to a reciprocating action. The resulting reciprocation will facilitate the movement of the cannula through the adipose tissue.
The provided documents are a 510(k) notification and related FDA correspondence for the Xomed XPS/PowerSculpt System. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive clinical study data with specific acceptance criteria and detailed performance metrics as expected for a typical AI/ML device submission.
Therefore, the requested information regarding acceptance criteria, specific study details (sample size, data provenance, expert adjudication, MRMC studies, standalone performance), and ground truth establishment is not available in these documents.
The documents focus on the device's design, intended use, and comparison to legally marketed predicate devices to establish substantial equivalence based on technological characteristics and safety/effectiveness.
Here's what can be extracted and why the other information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
- Not Applicable / Not Available. The 510(k) submission for the XPS/PowerSculpt System does not present specific acceptance criteria in the form of quantitative performance metrics (e.g., sensitivity, specificity, accuracy) that would be evaluated in a study with a test set. This type of evaluation is more common for diagnostic or AI/ML-driven devices.
- The FDA's substantial equivalence determination is based on the device having the same intended use and similar technological characteristics as predicate devices, without raising new questions of safety or effectiveness. The "performance" assessment is comparative, not based on meeting predefined numerical thresholds.
2. Sample Size Used for the Test Set and Data Provenance
- Not Available. The document does not describe a "test set" in the context of a performance study with human subjects or retrospective data for evaluating accuracy. The device is a surgical system for tissue removal. The "test" it undergoes is primarily verification and validation of its mechanical and electrical components, alongside comparative analysis with existing devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Not Applicable / Not Available. This device is a surgical instrument, not a diagnostic tool requiring expert consensus for ground truth.
4. Adjudication Method for the Test Set
- Not Applicable / Not Available. No test set or ground truth adjudication process is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Not Applicable / Not Available. An MRMC study is relevant for diagnostic devices where human readers interpret medical images or data. The XPS/PowerSculpt System is a surgical tool; therefore, this type of study is not relevant to its 510(k) submission.
6. Standalone (Algorithm Only) Performance Study
- Not Applicable / Not Available. This device is a mechanical surgical system, not an algorithm or AI model.
7. Type of Ground Truth Used
- Not Applicable / Not Available. As mentioned, the device is a surgical instrument. "Ground truth" in the context of diagnostic accuracy is not relevant here. The "truth" for this device would relate to its ability to perform its intended mechanical function safely and effectively, which is assessed through engineering tests and comparison to predicates.
8. Sample Size for the Training Set
- Not Applicable / Not Available. This device is a surgical instrument, not an AI/ML model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable / Not Available. Again, not an AI/ML model.
Summary of what the documents do provide related to equivalence:
- Device Name: XPS/PowerSculpt System
- Intended Use: For the removal of soft tissue and fluid from the body during general surgical procedures including suction lipoplasty for aesthetic body contouring.
- Predicate Devices:
- Substantial Equivalence Rationale: The XPS/PowerSculpt System is considered substantially equivalent because it has the "same intended use and the same technological characteristics" as the predicate devices. Specifically, it consists of a console, handpiece, and disposable cannulae. An adapter converts rotary action to reciprocating action, simulating the manual motion of a surgeon using a standard aspiration cannula, reducing manual effort, and facilitating penetration of adipose tissue. The "end result and performance" are claimed to be equivalent to the predicate devices.
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Xomed, Inc. David Timlin Manager Regulatory Affairs 6743 Southpoint Dr. North Jacksonville, Florida 32216-0980
June 8, 2021
Re: K992855
Trade/Device Name: Xps Straightshot Or Model 2000 Microdebrider System Or Xps Powersculpt Regulation Number: 21 CFR 878.5040 Regulation Name: Suction lipoplasty system Regulatory Class: Class II Product Code: OPB
Dear David Timlin:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated January 21, 2000. Specifically, FDA is updating this SE Letter because FDA has created a new product code to better categorize your device technology.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Cindy Chowdhury, OHT4: Office of Surgical and Infection Control Devices, 240-402-6647, Cindy.Chowdhury@fda.hhs.gov.
Sincerely,
Cindy Chowdhury -S
Cindy Chowdhury, Ph.D., M.B.A. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three stripes representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 21 2000
Mr. David Timlin Manager, Regulatory Affairs Xomed, Inc. 6743 Southpoint Drive North Jacksonville, Florida 32216-0980
Re: K992855 Trade Name: XPS/PowerSculpt System Regulatory Class: II Product Code: MUU Dated: December 8, 1999 Received: December 14, 1999
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 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,
Hinet Sagon
Ser James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| 510(k) Number (if known): | K992855 |
|---|---|
| Device Name: | XPS / PowerSculpt System |
| Indications for Use: |
The XPS/PowerSculpt System with reciprocating adapter and suction cannula is indicated for the removal of soft tissue and fluid from the body during general surgical procedures including suction lipoplasty for aesthetic body contouring.
(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)
Or
Over-the-Counter Use
(Optional Format 1-2-96)
Russell Sage
(Division Sion-Division of Ger 510(k) Numb
052
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K992855 (P.1 of 2)
510(k) Summary
- 1.0 Date Prepared August 20, 1999
- 2.0 Submitter (Contact) David Timlin Xomed Surgical Products Jacksonville, FL (904) 279-7532
3.0 Device Name
| Proprietary Name: | XPS StraightShot or Model 2000 Microdebrider Systemor XPS PowerSculpt(The proposed product tradename has not been finalizedand may be changed at a later date) |
|---|---|
| Common Name(s): | Electrical surgical debriders, Tissue aspirator, Suctionlipoplasty system and cannula |
| Classification Name: | Surgical instrument, AC powered motors andaccessories / attachmentsSuction lipoplasty system |
5.0 Device Classification
Surgical instrument, AC powered motors and accessories / attachments Procode 87HWE Class II ; 21 CFR 878.4820 Tier 1
Suction lipoplasty system Procode 79MFF Class II ; 21CFR 878.5040 Tier 2
6.0 Device Description
The Power Control Unit, handpiece and principle of operation remain essentially the same as described in K984363. The standard blades that are used for tissue debridement and aspiration will be replaced by suction cannulae equivalent in design to predicate suction lipoplasty cannulae. Lastly, a removable adapter, similar to the adapter cleared for rasping in K983025, will be provided to translate the rotary action of the handpiece to a reciprocating action. The
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992855 (R.A of 3)
resulting reciprocation will facilitate the movement of the cannula through the adipose tissue.
7.0 Intended Use
The Xomed XPS / PowerSculpt System with reciprocating adapter and suction rno Achea XF Or the removal of soft tissue and fluid from the body during general surgical procedures including suction lipoplasty for aesthetic body contouring.
Substantial Equivalence 8.0
The XPS/PowerSculpt System, with expanded indications for suction lipoplasty, is substantially equivalent to the following predicate devices that are currently marketed to dissect and remove adipose tissue:
| Powered SystemsMicroAire PAD-100 "Power Aspiration Device"(MicroAire Surgical Instruments) | K981922 |
|---|---|
| NuMED Power Cannula(NuMED or United American Medical) | 510k unknown |
| Aspiration CannulaeVarious cannulae (and aspirators)(Wells Johnson Company) | K832520 |
Like the predicate powered systems, the XPS/PowerSculpt System consists mainly of a console, a handpiece and disposable cannulae. Cuently, an adapter is proposed for use with the current XPS handpieces, to convert the rotary action of the handpiece to a reciprocating action. The end result and performance though is equivalent to the predicate devices ..
As with the predicate devices, the small (approx. 3 mm), but rapid reciprocation of the cannula simulates the manual motion of the surgeon using a standard aspiration cannula. Not only does this reduce the manual effort required by the surgeon, it facilitates the penetration of the cannula through the tissue.
The XPS/PowerSculpt System is substantially equivalent to the currently marketed predicates as it has the same intended use and the same technological characteristics as the predicate devices.
§ 878.5040 Suction lipoplasty system.
(a)
Identification. A suction lipoplasty system is a device intended for aesthetic body contouring. The device consists of a powered suction pump (containing a microbial filter on the exhaust and a microbial in-line filter in the connecting tubing between the collection bottle and the safety trap), collection bottle, cannula, and connecting tube. The microbial filters, tubing, collection bottle, and cannula must be capable of being changed between patients. The powered suction pump has a motor with a minimum of1/3 horsepower, a variable vacuum range from 0 to 29.9 inches of mercury, vacuum control valves to regulate the vacuum with accompanying vacuum gauges, a single or double rotary vane (with or without oil), a single or double diaphragm, a single or double piston, and a safety trap.(b)
Classification. Class II (special controls). Consensus standards and labeling restrictions.