(62 days)
Not Found
No
The summary describes a mechanical system for tissue removal and fluid suction, with no mention of AI, ML, image processing, or data-driven performance metrics.
No
The device is used for removal of soft tissue and fluid during general surgical procedures, including suction lipoplasty, which is a surgical tool rather than a therapeutic one providing a cure or treatment.
No
The device is described as being used for the "removal of soft tissue and fluid" and driving "burs, blades, drills, rasps, and reciprocating cannulae," which are all actions related to surgical intervention (treatment) rather than diagnosis.
No
The device description clearly outlines multiple hardware components including a power control console, footswitches, cables, and handpieces, indicating it is a hardware-based system, not software-only.
Based on the provided information, the XPS 3000 system is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the system is for the "removal of soft tissue and fluid during general surgical procedures including suction lipoplasty for aesthetic body contouring." This describes a surgical device used on the patient's body, not a device used to test samples from the body (which is the definition of an IVD).
- Device Description: The description lists components like a power control console, footswitches, cables, and handpieces that drive surgical tools (burs, blades, drills, rasps, reciprocating cannulae). These are all characteristic of surgical equipment, not IVD equipment.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), reagents, or any of the typical components or processes associated with in vitro diagnostics.
Therefore, the XPS 3000 system is a surgical device, not an IVD.
N/A
Intended Use / Indications for Use
The XPS 3000 system with reciprocating adapter and suction cannlua is intended for the removal of soft tissue and fluid during general surgical procedures including suction lipoplasty for aesthetic body contouring.
Product codes
QPB, MUU, GEY
Device Description
The XPS 3000 system consists of a power control console, footswitches, connection cables, and assorted handpieces to drive various burs, blades, drills, rasps, and reciprocating cannulae.
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
June 8, 2021
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA acronym along with the words "U.S. FOOD & DRUG ADMINISTRATION" on the right. The FDA part of the logo is in blue, with the acronym in a larger font size than the rest of the text.
Medtronic Xomed, Inc. Martin Sargent Regulatory Affairs Manager 6743 Southpoint Dr. North Jacksonville, Florida 32216
Re: K010666
Trade/Device Name: Xps 3000 System With Reciprocating Adapter And Suction Cannulae Regulation Number: 21 CFR 878.5040 Regulation Name: Suction lipoplasty system Regulatory Class: Class II Product Code: QPB
Dear Martin Sargent:
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 May 7, 2001. 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
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle are three stylized human profiles facing to the right, stacked one above the other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 7 2001
Mr. Martin Sargent Regulatory Affairs Manager Medtronic Xomed 6743 Southpoint Drive North Jacksonville, Florida 32216
Re: K010666
Trade/Device Name: XPS 3000 System Regulation Number: 878.5040 Regulatory Class: II Product Code: MUU Dated: March 5, 2001 Received: March 6, 2001
Dear Mr. Sargent:
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 atoted in the enclosure) to legally marketed predicate 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 requirements, 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.
2
Page 2 - Mr. Martin Sargent
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 nredicate 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) 594-4659. 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" (21CFR 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/dsma/dsmamain.html".
Sincerely yours,
Hthlellp on
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
KO10666 510(k) Number (if known): Device Name: XPS 3000 System Indications for Use:
The XPS 3000 system with reciprocating adapter and suction cannlua is intended for the removal of soft tissue and fluid during general surgical procedures including suction lipoplasty for aesthetic body contouring.
Architecture for cmu
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K010666
(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)
4
MAY - 7 2001
p. 1/2
510(k) Summary
1.0 Date Prepared
March 5, 2001
2.0 Submitter (Contact)
Martin D. Sargent Regulatory Affairs Manager Medtronic Xomed Jacksonville, FL (904) 279-7586
3.0 Device Name
| Proprietary Name: | XPS 3000 System with reciprocating adapter and suction cannulae |
|---|---|
| Common Name(s): | Electrical surgical shavers, electrical debriders, drill handpieces and |
| cutting blades, burs, rasps, reciprocating hadpieces, and cannulae | |
| Classification Name(s): | Suction lipoplasty system and accessories; |
| Surgical instrument. AC powered motors, accessories and attachments |
4.0 Device Classification
| Classification Name: | Suction lipoplasty system |
|---|---|
| Procode 79MFF | Class II 21 CFR § 878.5040 |
| Classification Name: | Suction lipoplasty accessories |
| Procode 79MUU | Class II 21 CFR § 878.5040 |
| Classification Name: | Surgical instrument, AC powered motors, accessories and attachments |
| Procode 79GEY | Class I 21 CFR § 878.4820 |
5.0 Device Description
The XPS 3000 system consists of a power control console, footswitches, connection cables, and assorted handpieces to drive various burs, blades, drills, rasps, and reciprocating cannulae.
5
510(k) Summary (continued) KO10666
6.0 Indications for Use
The XPS 3000 with reciprocating adapter and suction cannlua is intended for the removal of soft tissue and fluid during general surgical procedures including suction lipoplasty for aesthetic body contouring.
Substantial Equivalence 7.0
The proposed XPS 3000 system is substantially equivalent in operating principle, technology, overall design, function, materials, and intended use to the XPS / Powersculpt System as decribed in K992855.