(113 days)
The Tissu Trans Filtron is intended to be used with house vacuum and/or cleared pumps, tubing and cannulas, for the collection of aspirated fat, for aesthetic body contouring. If the fat is untreated, it may be reinjected via a cleared injection apparatus.
Tissu Trans Filtron is used in the aspiration, harvesting, filtering and transferring of autologous tissue,
Tissu Trans Filtron is intended for use in the following surgical specialties when the aspiration of soft tissue is desired:
- Plastic and Reconstructive Surgery
- Neurosurgery
- Gastrointestinal and Affiliated Organ surgery
- Urological Surgery
- Orthopedic surgery
- Gynecological Surgery
- Thoracic surgery
- Laparoscopic Surgery
The Tissu Trans Filtron is provided in a sterile, two piece packaged assembly: The Tissu Trans Filtron. The Tissu Trans Filtron is a single-use, sterile, disposable device designed to utilize an FDA, cleared house vacuum to create suction within the physician supplied hollow liposuction cannula and remove subcutaneous fatty tissue from the patient and transport the autologous tissue into the collection canister.
The Tissu Trans Filtron is a sterile, single-use, manual device consisting of a medical grade polycarbonate canister, a medical grade polypropylene lid with various ports, medical grade silicone connection tubings for aspiration of waste, harvesting of tissue and transferring of filtered autologous tissue. A polypropylene clamp is included for clamping off the tubing as needed. A medical grade polyester mesh filter lining is contained within the canister.
The provided text is a 510(k) summary for the Shippert Medical Technologies Tissu Trans Filtron, a suction lipoplasty system. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study proving the device meets them as would be seen in a clinical trial for a new therapeutic device.
Here's an analysis based on the provided text, addressing your points where information is available:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria for device performance. Instead, it relies on demonstrating substantial equivalence to existing, legally marketed predicate devices. The "reported device performance" is summarized as being "safe and effective," and performing "as desired," implying it met the functional expectations for a device of its type and was comparable to the predicates in terms of safety and efficacy.
| Acceptance Criteria (Implicit from Substantial Equivalence) | Reported Device Performance |
|---|---|
| Material Biocompatibility: Components in indirect patient contact meet ISO 10993 for External Communication Devices, Tissue contact, < 24 hours. | All components passed ISO 10993 testing regimen for External Communication Devices, Tissue contact, of less than 24 hours. Biocompatibility testing was performed on the sterile, finished device. |
| Sterility: Device is sterile. | The Tissu Trans Filtron is sterilized by Gamma Radiation. |
| Mechanical Performance: Device functions as intended for aspiration, harvesting, filtering, and transferring autologous tissue. | Mechanical testing demonstrates the device is substantially equivalent to the predicate device. Clinical testing performed by Ronald Shippert, M.D. demonstrated the device performed as desired and was safe and effective. |
| Safety and Effectiveness (Clinical): Device is safe and effective for its intended use (collection of aspirated fat for aesthetic body contouring; if untreated, reinjection). | Clinical testing performed by Ronald Shippert, M.D., proved to be safe and effective. The device performed as desired and was as safe and as effective as the predicate devices. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "clinical testing performed by Ronald Shippert, M.D." but does not specify the sample size for this clinical testing. It also does not provide information on the country of origin or whether the data was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
The document mentions "clinical testing performed by Ronald Shippert, M.D." as validating the device's performance, implying he acted as an expert. No other experts are mentioned, nor are specific qualifications beyond "M.D." provided. Given the context of a 510(k) summary for a medical device used in aesthetic procedures, Ronald Shippert, M.D., is likely a surgeon with experience in lipoplasty.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
No information on adjudication methods is provided in the document.
5. 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
No MRMC comparative effectiveness study was done. This device is a physical medical device (suction lipoplasty system), not an AI-driven diagnostic tool, so such a study would not be applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for device performance appears to be based on the subjective assessment of "safety and effectiveness" by a medical professional, Ronald Shippert, M.D., likely through observing surgical outcomes and device functionality during procedures. Given the nature of a lipoplasty system, "outcomes data" in terms of successful fat aspiration and contouring, as well as absence of adverse events, would form the practical ground truth, evaluated by the operating physician. No objective pathology or extensive outcomes data is explicitly mentioned beyond the physician's assessment.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/machine learning device.
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Shippert Medical Technologies
The Denver Splint Company
6248 S. Troy Circle, Unit A Centennial, CO 80111 Telephone 1-800-888-8663 (303) 754-0044 Facsimile 1-800-284-0864 (303) 754-0318 Website www.shippertmedical.com
DEC - 4 2009
510(k) SUMMARY Section 5:
| K 092482 | 510(k) Summary | Tissu Trans Filtron | Page 1 of 5 |
|---|---|---|---|
| ---------- | ---------------- | --------------------- | ------------- |
| Name: | Shippert Medical Technologies6248 South Troy Circle, Unit ACentennial, Colorado 80111 |
|---|---|
| Tele: | 303.754.0044 |
| Fax: | 303.754.0318 |
| Date: | December 4, 2009 |
|---|---|
| ------- | ------------------ |
| Official Contact: | Sarah Lake Shippert |
|---|---|
| email: sarah@shippertmedical.com | |
| Telephone (303) 888.4965 |
| Submitted by: | Sarah Lake Shippert |
|---|---|
| --------------- | --------------------- |
FDA ESTABLISHMENT REGISTRATION NUMBER: 1718903
DEVICE NAME: Tissu Trans Filtron
| Tradename: | Tissu Trans Filtron |
|---|---|
| Common Name: | Suction Lipoplasty System |
| Classification name: | Suction Lipoplasty System |
| Tradename: | Tissu Trans Filtron |
|---|---|
| Common Name: | Suction Lipoplasty System |
| Classification name: | Suction Lipoplasty System |
| Product Code: | MUU |
| Regulation Number: | 21 CFR 878.5040 |
| Class II | Sterile |
DEVICE CLASSIFICATION AND PRODUCT CODE:
As shown in 21 CFR 878.5040 Suction Lipoplasty Systems are defined as devices consisting of collection bottles, cannulas, and connecting tubing for use in aesthetic body contouring procedures. Suction Lipoplasty Systems are classified as Class II. They have been assigned Product Code MUL.
20 191841836.
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092482 4/5
K 092482
-10(k) Summary
510(k) Summary
INDICATIONS FOR USE:
The Tissu Trans Filtron is intended to be used with house vacuum and/or cleared pumps, tubing and cannulas, for the collection of aspirated fat, for aesthetic body contouring. If the fat is untreated, it may be reinject rid, it a cleared injection apparatus.
INTENDED USE:
The Tissu Trans Filtron is intended to be used with house vacuum and/or cleared pumps, tubing and cannulas, for the collection of aspirated fat, for aesthetic boody contouring. If the fat is untreated, it may be reinjected via a cleared injection apparatus.
Tissu Trans Filtron is used in the aspiration, harvesting, filtering and transferring of autologous tissue,
Tissu Trans Filtron is intended for use in the following surgical specialties when the aspiration of soft tissue is desired:
-
Plastic and Reconstructive Surgery
-
Plastic and Reconstructive Surgery
Neurosurgery
Gastrointestinal and Affiliated Organ surgery With I . Suspins
Gastrointestinal and Affiliated Organ surgery Housery Housery -
Urological Surgery
-
Orthopedic surgery .
-
Gynecological Surgery
-
Thoracic surgery
-
Laparoscopic Surgery
DESIGN CHARACTERISTICS: 2 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 The Tissu Trans Filtron is provided in a sterile, two piece packaged assembly: The Tissu Trans Filtron. The Tissu Trans Filtron is a single-use, sterile, disposable device designed to utilize an FDA, cleared house vacuum to create suction within the physician supplied hollow liposuction cannula and remove subcutaneous fatty tissue from the patient and transport the autologous tissue into the collection canister. The patient and transport the adiologics than
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c092482315
K 092482 510(k) Summary
Tissu Trans Filtron
Page 3 of 5
12 at 19
DEVICE COMPONENTS:
The Tissu Trans Filtron is a sterile, single-use, manual device consisting of a medical grade polycarbonate canister, a medical grade polypropylene lid with various ports, medical grade silicone connection tubings for aspiration of waste, harvesting of tissue and transferring of filtered autologous tissue. A polypropylene clamp is included for clamping off the tubing as needed. A medical grade polyester mesh filter lining is contained within the canister.
Material Composition:
The components of the Tissu Trans Filtron do not have direct patient contact. The necessary FDA cleared liposuction cannula (direct patient contact) is supplied by the physican.
All components of the Tissu Trans Filtron have been tested and have passed the ISO 10993 testing regimen for External Communication Devices, Tissue contact, of less than 24 hours. All necessary biocompatibility testing was performed on the sterile, finished device.
STERILITY:
The Tissu Trans Filtron is sterilized by Gamma Radiation.
IN VITRO TESTING:
Mechanical testing of the Tissu Trans Filtron demonstrates that the device is substantially equivalent to the predicate device. Device Performance was satisfied by clinical testing performed by Ronald Shippert, M.D. All testing proved to be safe and effective. The device performed as desired and was as safe and as effective as the predicate devices.
EQUIVALENCE TO MARKETED DEVICES:
The Tissu Trans Filtron share indications and design principles with the following predicate devices which have been determined by FDA to be substantially equivalent to premarket devices: Cytori AFT System K072587 Tissu Trans K050797, and Genesis Biosystems Lipivage (510(k) number unknown); Class I and Class II medical devices that were cleared for marketing in the United States.
Design and Materials:
The design and materials of the Tissu. Trans Filtron and the predicate devices, (Cytori AFT System 072587, Shippert Medical Tissu Trans k 050797, Genesis Biosystems Lipivage id unknown, are substantially equivalent, as they are all single-use, polymer constructed, manually operated systems that utilize manual.
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ar son the call home . and ... .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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c0474824/5
K 092482 510(k) Summary
Tissu Trans Filtron
Page 4 of 5
or external sources of vacuum to withdraw, hold, and/or inject fluids/tissues into the body. The Tissu Trans Filtron is substantially equivalent to the Cytor AFT System K072587, The Shippert Medical Tissu Trans K050797 and the Lipivage k# unknown, predicate devices as they all consist of a polycarbonate tissue collection canister and they share design principles of utilizing an FDA cleared house-vacuum to aspirate adipose tissue from the patient and subsequently transport the adipose tissue through a tube into a cylindrical collection chary that contains a filtering mechanism of pores to allow fluids to pass, but retains the adipose tissue within the filter chamber. The Tissu Trans Filtron is substantially equivalent to the Cytori AFT System K072587, Shippert Medical's Tissu Trans 050797 and Genesis Biosystems Lipivage k# unknown, as they all have connection ports on the superior ends of the housing chamber for the attachment of suction tubing/stainless steel cannulas that contact the patient and connection ports on the inferior end of the housing chamber to connect to vacuum tubing that draws house vacuum and carries waste to the waste trap.
Substantial Equivalence: _Shippert Medical Technologies claim substantial equivalence to the predicate devices. Predicate Device # 1: Cytori AFT System , k 072587 Classification Name: Suction Lipoplasty System
Class 2 Device, Product Code MUU 、 Concrol Hoopital Olamber 878.5040 at at a polycharners 31 2 11-2 General Hospital Classification Advisory Committee [-General & Plastic Surgery Review Advisory Committee ചിത്രീരത്തിനു
and
Predicate Device # 2: Shippert Medical's " Tissu Trans", K050797
Classification name: Syringe, Irrigating ( Non Dental) Class 1 Device, Sterile 11 - 11 ្រ : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : :
Product Code: KYZ Regulation #: 880.6960.net=" +t-chaitact the pating(the should and conner General Hospital Classification Advisory Committee General & Plastic Surgery Review Advisory Committee
and
Predicate Device # 3
Genesis Biosystems Lipivage k# unknown
Classification name:
Class 2 Device, Sterile
Product Code: MUU Stiction | proplesty System
Regulation #: 878.5040
General Hospital Classification Advisory Committee General & Plastic Surgery Review Advisory Committee
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1-092482 5/5
K 092482
O(k) Summary:
510(k) Summary
-
- Page 5 of 5
Summary: The Shippert Medical Tissu Trans Filtron device described in this submission is substantially equivalent to the predicate devices and is safe and effective. The proposed device and predicate devices have identical "Internded Use" and similar Indications For Use" and also share similar design and technological principles. The device design and materials used are similar to those of the Predicate Devices, Cytori AFT System k 072587, Shippert Medical Tissu Trans, K05079 and Genesis Biosystems Lipivage k# unknown,
As stated in CFR 878.5040, (product code MUU),
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 connection 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 of 1/3 horsepower, a variable vacuum range from 0 - 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.
Given the "Intended Use", "Indications For Use", device technology, materials and basic design structure of Product Code MUU, & KYZ, Shippert,Medical Technologies claim Substantial Equivalence to the above listed devices.
Bred Callen plant (CC . 1 ago to ways a more al instine niters in the bonnection But safety trap), collection bo tually : collegeli
ICL
{5}------------------------------------------------
Tissu Trans Filtron™ Indications For Use; The Tissu Trans Filtron Is intended to be used with house vacuum and/or cleared The Tissu Trans Filtron is intenced to be used into notated for aesthetic body
pumps, tubing and cannot to the collection, of aspirated for a segment of the color appar pumps, tubing and cannulas, for the collections. It is a cleared injection apparatur Tissu Trans Filtron is used in the aspiration in and transfering of anyalting of a viralize of Soft tissue is Tissu Trans Filtron is used in the following surgical specialites when the aspection of soft tissue is
Trans Filtron is intended for use in the following surgical and Afrikan Trans Filtron's intended for use in the rolowing sorginal and Afiliated Organ Surgery.
desired: Plastic and Reconstructive Surgery, NEIrosellent Laborosophy, Surgey. desired: Plastic and Reconstructive Surgery, Neurosal Surgery, Thoracic Surgery, Labaroscopic Surgery, Labaroscopic Surgery, Product Code: 3-TT-Filtron 2000-500 Contents: 1 Tissu Trans Filtron Unit with 6" Harvest Tubling <. 1 7" Transfer Tubing with Luer Lock Precaudons Section 4. Results of this procedure may or Warnings Section I. This device is designed to contour I , This device will not, in and of may not be permanent. sy not be permanent.
5. The amount of far removed should the body by removing localized deposits self. produce significans welght of excess fat through small Incisions be limited to that necessary to achleve reduction. 2. Use of this device is limited to destred cosmelle effoci. 2. This device should be used with desired cosment smoonents of the those physicians who, by means of extreme caucion in patients with formal professional training or device must be sterlilized and all chronic medical condicions. such as disposable components replaced before sanctioned continuing medical dlaberes: heart, lung, or circulatory education (including supervised using the device system on another system disease; or obestry. operative experience), have attained 3. The volume of blood loss and patient ... proficiancy in suction lipoplasty. endogenous body Nuld loss may 3. Results of this procedure will vary adversely affect Intra and/or depending upon pratient age, surgical postopersilve hemodynamic stablily and experience of the physician. and patient safety. The copability of providing adequate. Ilmely replacement Is essencial for patient safety. ilng and transferring a n the asoil Saltes Va . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . WARNING (S) :: 1 DO NOT REUSE OR RESTERILIZE. STERILE R INTENDED FOR SINGLE PATIENT USE - 11047 USE ONLY WITH A MEDICAL GR 2009-06 VACUUM OR ASPIRATOR APPA Consult lastructions for Use · Pyrogen Free, Rx Only Caution: Federal law restricts 3951DB Maart this device to sale by or on the The Netherland order of a physician. Contants of unopened, undamaged package Are STERILE AND NON-PYROGENTC. 000-888-8553 phone 84-0884 14 13.3 operimedical.com 1 2 0137
{6}------------------------------------------------
Shippert Medical Technologies
The Denver Splint Company
6248 S. Troy Circle, Unit A Centennial, CO 80111 Telephone 1-800-888-8663 (303) 754-0044 Facsimile 1-800-284-0664 (303) 754-0318 Website www.shippertmedicul.com
2:13:1
Similar : . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Tele, 1.1.
.iı:••
December 4, 2009
Mr. George Ngatha FDA CDRH 10903 New Hampshire Avenue Silver Spring, MD 20993
Dear George, Dear George,
Enclosed please find the requested documents for 510k 092482:
Revised Indications For Use Revised Summary.
Hard copies will follow by mail along with revised labeling.
Thank you,
Yarich Shippert
Sarah Lake Shippert
{7}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/7/Picture/1 description: The image shows the seal for the Department of Health & Human Services (HHS). The seal is composed of two main elements: a circular text border and a central emblem. The text border reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. The emblem features a stylized depiction of an eagle with outstretched wings, symbolizing the department's mission to protect and promote the health and well-being of the nation.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Shippert Medical Technologies Corp. % Ms. Sarah Shippert Head, Regulatory Affairs 6428 South Troy Circle, Unit A Centennial, Colorado 80111
Re: K092482
Trade/Device Name: Tissu Trans Filtron Regulation Number: 21 CFR 878.5040 Regulation Name: Suction lipoplasty system Regulatory Class: II Product Code: MUU Dated: November 17, 2009 Received: November 27, 2009
DEC - 4 2009
Dear Ms. Shippert:
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. 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 (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.
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
{8}------------------------------------------------
Page 2 - Ms. Sarah Shippert
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Joxutti
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{9}------------------------------------------------
Indications For Us
510k Number if known: K092482
Device Name: Tissu Trans Filtron
Indications for Use:
The Tlssu Trans Filtron is intended to be used with house vacuum and/or cleared pumps, tubing and cannulas, for the collection of aspirated fat, for aesthetic body contouring. If the fat is untreated, it may be reinjected via a cleared injection apparatus.
Prescription Use Over-The
11 15 - - 45
(Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
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David Kramer
(Division-Sign-Off)
1 - 124
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510(k) Number K092462
§ 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.