(233 days)
Not Found
No
The description focuses on mechanical components and procedures for fat grafting, with no mention of AI or ML.
Yes.
The device facilitates a medical procedure (autologous fat grafting) that involves harvesting, centrifuging, and reinjecting adipose tissue, which is a therapeutic intervention.
No
The device is intended for the harvesting, centrifuging, and reinjection of autologous adipose tissue, which are procedural steps, not diagnostic functions.
No
The device description explicitly states it is a "sterile (EtO) single use disposable pack" containing physical components like syringes, cannulas, needles, containers, and a nut for a centrifuge. This indicates it is a hardware-based medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a procedure involving the harvesting, processing, and reinjection of autologous adipose tissue within the same procedure. This is a surgical/medical procedure performed on the patient's body, not a test performed in vitro (outside the body) on a sample to diagnose a condition.
- Device Description: The device description details components used for this surgical procedure (syringes, cannulas, containers, etc.), not reagents or equipment for analyzing biological samples.
- Performance Studies: The performance studies focus on the physical and functional characteristics of the device for its intended surgical use (pressure resistance, connection strength, biocompatibility, cell viability of the processed tissue), not on the accuracy or reliability of a diagnostic test.
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 is used to manipulate and reintroduce tissue into the body for therapeutic purposes.
N/A
Intended Use / Indications for Use
The KTA Adipose Treatment Kit is intended for medical and surgical procedures involving autologous fat grafting that consists in: -harvesting, -centrifuging, and -reinjecting autologous adipose tissue, Within the same procedure.
The KTA Adipose Treatment Kit range consists in a family of products which are designed to harvest, process with minimal manipulation and reinject small - KTAMICRO, KTAEASY, KTAMY - to large -KTAMACRO, KTAMACROMED, KTASPIN - volumes of autologous fat in the following specialties:
Neurosurgery, Gastrointestinal Surgery, Urological Surgery, Plastic and Reconstructive Surgery, General Surgery, Orthopedic Surgery, Gynecological Surgery, Thoracic Surgery, Laparoscopic Surgery, Arthroscopic Surgery,
Product codes (comma separated list FDA assigned to the subject device)
MUU
Device Description
The KTA Adipose Treatment Kit consists of a sterile (EtO) single use disposable pack used for the aspiration, harvesting, centrifuging and reinjection of autologous adipose tissue during the same procedure. Each kit contains the necessary equipment such as syringes, cannulas, needles, containers, Luer Lock caps / connectors and a standard M8 single use nut for the centrifuge.
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)
Bench testing has been performed to demonstrate the substantial equivalence of the devices to the predicates. Bench testing included: shipping validation, real time and accelerated aging, usability testing, connections compatibility (connective forces and connection seal strength), maximum pressure and vacuum, dimensional analysis, resistance to corrosion, assembly testing, biocompatibility testing, and cell viability testing.
In accordance with ISO 10993-1, KTA Adipose Treatment Kit is categorized as an external communicating device with limited contact duration (
§ 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
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October 10, 2019
Stemics S.A.S % Catherine Gloster President Gloster Biomedical International, LLC 577 North Hope Avenue Santa Barbara, California 93110
Re: K190386
Trade/Device Name: KTA Adipose Treatment Kit Regulation Number: 21 CFR 878.5040 Regulation Name: Suction Lipoplasty System Regulatory Class: Class II Product Code: MUU Dated: February 15, 2019 Received: February 19, 2019
Dear Ms. Gloster:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
For Cindy Chowdhury, Ph.D., M.B.A. Acting 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
Enclosure
2
Indications for Use
510(k) Number (if known) K190386
Device Name KTA Adipose Treatment Kit
Indications for Use (Describe) The KTA Adipose Treatment Kit is intended for medical and surgical procedures involving autologous fat grafting that consists in: -harvesting, -centrifuging, and -reinjecting autologous adipose tissue, Within the same procedure.
The KTA Adipose Treatment Kit range consists in a family of products which are designed to harvest, process with minimal manipulation and reinject small - KTAMICRO, KTAEASY, KTAMY - to large -KTAMACRO, KTAMACROMED, KTASPIN - volumes of autologous fat in the following specialties:
Neurosurgery, Gastrointestinal Surgery, Urological Surgery, Plastic and Reconstructive Surgery, General Surgery, Orthopedic Surgery, Gynecological Surgery, Thoracic Surgery, Laparoscopic Surgery, Arthroscopic Surgery,
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
(7 STEMCIS
510(k) Summary
| Submission Date: | 10/6/2019 |
|---|---|
| K190386 | |
| SUBMITTER INFORMATION | |
| Company Name: | STEMCIS SAS |
| Company Address: | 2 rue du Professeur Paul Milleret |
| 25000 Besançon | |
| FRANCE | |
| Contact Person: | Stéphane Giraud |
| +33 967 501 298 | |
| Email: stephane.giraud@stemcis.com |
DEVICE INFORMATION
| Trade Name: | KTA Adipose Treatment Kit |
|---|---|
| Common Name: | Adipose Treatment Kit |
| Classification Name: | 21CFR 878.5040 |
| Device Class: | Class II |
| Product code: | MUU |
| Predicate Devices: | K081848 Lipose Fat Transfer System |
| K121005 Harvest AdiPrep™ Adipose Transfer System | |
| Device Description: | The KTA Adipose Treatment Kit consists of a sterile (EtO) single use |
| disposable pack used for the aspiration, harvesting, centrifuging and | |
| reinjection of autologous adipose tissue during the same procedure. | |
| Each kit contains the necessary equipment such as syringes, | |
| cannulas, needles, containers, Luer Lock caps / connectors and a | |
| standard M8 single use nut for the centrifuge | |
| Indications for Use: | The KTA Adipose Treatment Kit is intended for medical and surgical |
| procedures involving autologous fat grafting that consists in: | |
| • Harvesting, | |
| • Centrifuging, and | |
| • Reinjecting autologous adipose tissue, | |
| Within the same procedure. |
The KTA Adipose Treatment Kit range consists in a family of products
which are designed to harvest, process with minimal manipulation
and reinject small – KTAMICRO. KTAEASY, KTAMY – to large – |
4
(ĮSTEMCIS
| | KTAMACRO, KTAMACROMED, KTASPIN – volumes of autologous fat
in the following specialties:
Neurosurgery, Gastrointestinal Surgery, Urological Surgery, Plastic
and Reconstructive Surgery, General Surgery, Orthopedic Surgery,
Gynecological Surgery, Thoracic Surgery, Laparoscopic Surgery,
Arthroscopic Surgery. | |
|----------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Performance Data: | Bench testing has been performed to demonstrate the substantial
equivalence of the devices to the predicates. Bench testing included:
shipping validation, real time and accelerated aging, usability testing,
connections compatibility (connective forces and connection seal
strength), maximum pressure and vacuum, dimensional analysis,
resistance to corrosion, assembly testing, biocompatibility testing,
and cell viability testing. | |
| Technological Characteristics
and Comparison to Predicate
Device(s): | This submission describes the KTA Adipose Treatment Kit as
compared to the predicate devices. Based on the intended use,
design, materials, and technological characteristics presented in this
premarket notification as summarized in the Table below, the
STEMCIS KTA Adipose Treatment Kit has been shown to be
substantially equivalent to the currently marketed predicate devices. | |
SUBSTANTIAL EQUIVALENCE COMPARISON CHART
| Features | Subject device
KTA range | K081848 Predicate | K121005 Predicate |
|-------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification and
regulation number | System, Suction, Lipoplasty
21CFR 878.5040 | System, Suction, Lipoplasty
21CFR 878.5040 | System, Suction, Lipoplasty
21CFR 878.5040 |
| Product code | MUU | MUU | MUU |
| Features | Subject device
KTA range | K081848 Predicate | K121005 Predicate |
| Indications for use
& intended use | The KTA Adipose Treatment
Kit is intended for medical and
surgical procedures involving
autologous fat grafting that
consists in:
• Harvesting,
• Centrifuging, and
• Reinjecting
autologous adipose
tissue,
| The Lipose Fat Transfer
System is intended to be
used in the aspiration,
harvesting, and reinjecting of
autologous fat | The AdiPrep™ Adipose
Transfer System is used in
medical procedures involving
the harvesting and
transferring of autologous
adipose tissue. The AdiPrep™
system is used for
concentrating adipose tissue
harvested with a legally
marketed system.
The AdiPrep™ adipose
transfer system is intended
for use in the following
surgical specialties when the
concentration of harvested
adipose tissue is desired.
Neurosurgery,
Gastrointestinal Surgery,
Urological Surgery, Plastic
and reconstructive Surgery,
General Surgery, Orthopedic
Surgery, Gynecological
Surgery, Thoracic Surgery,
Laparoscopic Surgery,
Arthroscopic Surgery |
| Technological
characteristics
Processing pack
components | Components-syringes with
removable plunger, centrifuge
tubes with filter, aspiration &
fat injection cannula, fat
injection syringes, skin
puncture needles, and oil
extraction syringe & needle.
Cannula & syringes composed
of medical grade plastics | Components-syringes with
removable plunger,
centrifuge tubes with filter,
aspiration & fat injection
cannula, fat injection
syringes, skin puncture
needles, and oil extraction
syringe & needle | Components-syringes with
removable plunger,
centrifuge tubes with filter,
aspiration & fat injection
cannula, fat injection
syringes, skin puncture
needles, and oil extraction
syringe & needle. Cannula &
syringes composed of
medical grade plastics |
| Sterilization
method | Ethylene-Oxide Gas (EtO) | Gamma radiation | Ethylene-Oxide Gas (EtO) |
| Sterility Assurance
Level | SAL 10-6
Shelf life: 3 years | SAL 10-6 | SAL 10-6 |
| Features | Subject device
KTA range | K081848 Predicate | K121005 Predicate |
| Packaging | Tyvek® sealing | Tyvek® sealing | Tyvek® sealing |
| Disposable or
reusable | Single use, disposable | Single use, disposable | Single use, disposable |
| Biocompatibility | Biocompatible | Biocompatible | Biocompatible |
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(7 STEMCIS
6
OSTEN
NON-CLINICAL PERFORMANCE DATA
SAFETY BENCH TESTING
In accordance with ISO 10993-1, KTA Adipose Treatment Kit is categorized as an external communicating device with limited contact duration (