(150 days)
No
The description focuses on mechanical components and actions (reciprocating adapter, suction cannula, rotary action translated to reciprocating action) and makes no mention of AI or ML.
Yes
Explanation: The device is indicated for "removal of soft tissue and fluid from the body during general surgical procedures including suction lipoplasty for aesthetic body contouring," which are therapeutic interventions.
No
Explanation: The device is indicated for the removal of soft tissue and fluid and for suction lipoplasty, which are surgical procedures, not diagnostic ones.
No
The device description explicitly mentions hardware components such as a Power Control Unit, handpiece, reciprocating adapter, and suction cannula.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "removal of soft tissue and fluid from the body during general surgical procedures including suction lipoplasty for aesthetic body contouring." This describes a surgical procedure performed on the body, not a test performed on samples taken from the body to diagnose a condition.
- Device Description: The description details a system for physically removing tissue and fluid using suction and a reciprocating cannula. This is a surgical tool, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting substances, or providing diagnostic information based on in vitro testing.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening. This device's function is entirely focused on a surgical intervention.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
OPB, MUU
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 resulting reciprocation will facilitate the movement of the cannula through the adipose tissue.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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.
K981922, 510k unknown, K832520
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
§ 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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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 System
or XPS PowerSculpt
(The proposed product tradename has not been finalized
and may be changed at a later date) |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name(s): | Electrical surgical debriders, Tissue aspirator, Suction
lipoplasty system and cannula |
| Classification Name: | Surgical instrument, AC powered motors and
accessories / attachments
Suction 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
5
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 Systems
MicroAire PAD-100 "Power Aspiration Device"
| (MicroAire Surgical Instruments) | K981922 |
|---|---|
| NuMED Power Cannula | |
| (NuMED or United American Medical) | 510k unknown |
| Aspiration Cannulae | |
| Various 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.