(9 days)
Not Found
No
The device description and intended use focus on mechanical processes for tissue collection and transfer, with no mention of AI/ML or related concepts like image processing, data analysis, or algorithmic decision-making.
No.
The device is a sterile, single-use, disposable accessory used for the aspiration, harvesting, filtering, and transferring of autologous tissue, not for providing a therapeutic effect on the body itself. Its primary function is collection and preparation of tissue for re-injection.
No
The device description and intended use clearly state that it is for the collection, aspiration, harvesting, filtering, and transferring of autologous tissue for aesthetic body contouring or reinjection, not for diagnosing any condition.
No
The device description clearly states it is a sterile, single use, disposable device consisting of a canister and syringes, indicating it is a physical hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the collection, filtering, and transferring of aspirated fat and autologous tissue for aesthetic body contouring and reinjection. This is a surgical procedure involving the manipulation of tissue within the body, not the examination of samples in vitro (outside the body) for diagnostic purposes.
- Device Description: The description details a sterile, single-use device used for collecting and storing harvested tissue in syringes for immediate reinjection. This aligns with a surgical tool for tissue handling, not a diagnostic test.
- Lack of Diagnostic Claims: There are no mentions of analyzing samples, detecting biomarkers, diagnosing conditions, or providing information for diagnosis.
- Focus on Surgical Specialties: The listed surgical specialties further reinforce the device's role in surgical procedures.
IVD devices are typically used to examine samples like blood, urine, or tissue outside the body to provide information about a person's health status, diagnose diseases, or monitor treatment. This device's function is entirely focused on the physical handling and transfer of tissue during a surgical procedure.
N/A
Intended Use / Indications for Use
Tissu Trans Filtron Syringe Fill 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 Syringe Fill is used in the aspiration, harvesting, filtering and transferring of autologous tissue.
Tissue 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 .
- General Surgery
- Orthopedic Surgery .
- Gynecological Surgery .
- Thoracic Surgery .
- Laparoscopic Surgery
Product codes (comma separated list FDA assigned to the subject device)
MUU
Device Description
Shippert Medical's Tissu Trans Filtron Syringe Fill is a sterile, single use, disposable device used in the aspiration, harvest, filtering and transferring of autologous tissue. Used by physicians in the harvesting of body tissues, this device is a single use, disposable sterile canister with six enclosed 60cc syringes used for collecting the harvested tissue after harvesting/aspiration. The harvested tissue is stored in the Syringe Fill syringes and is intended for immediate reinjection of the harvested tissue back into the donor patient.
The Tissu Trans Filtron Syringe Fill connects to the inverted Tissu Trans Filtron, K092482, with an accessory silicone tubing piece which is included in the Tissu Trans Filtron Syringe Fill packaging. This tubing is connected onto the the Tissu Trans Filtron Syringe Fill's lid at the appropriate in-take port. This same transfer tubing is then connected onto the inverted Tissu Trans Filtron at its out-take port. The vacuum tubing from the Tissu Trans Filtron is repositioned from the Tissu Trans Filtron's vacuum port to the Tissue Trans Filtron Syringe Fill's vacuum port. When the vacuum pump is turned on the Tissu Trans Filtron Syringe Fill's six syringes begin to fill up as the physician releases the pinch clamp. As one syringe is filled, the tissue continues to fill the subsequent syringes. A pinch clamp is used to close off the silicone transfer tubing after the final sixth syringe is filled and the vacuum pump is turned off. The physician or OR staff will remove the filled syringes and place a physician supplied FDA approved re-injection cannula onto the syringe's luer lock. The syringe's plunger will be inserted at the large open end of the syringe and re-injection of the autologous tissue can proceed.
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
Physicians in hospital or facility settings.
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)
Clinical testing was conducted by Ronald D. Shippert, M.D. to validate and verify that the proposed device met all design specifications. Validation tests were conducted to validate the design control activity. Performance of the Tissu Trans Filtron Syringe Fill satisfies all design specifications. Mechanical testing of the Tissu Trans Filtron Syringe Fill 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 device.
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.
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.
0
510(k) SUMMARY Section 19:
k# 102117
As required by 807.97
Prepared By:
Shippert Medical Technologies . 6248 South Troy Circle, Unit A Centennial, Colorado 80111 Tele: 303.754.0044 Fax: 303.754.0318 Contact: Sarah Lake Shippert Email: sarah@shippertmedical.com Date: July 20, 2010
SPECIAL 510(k) APPLICATION
AUG - 6 2010
Telephone ( 303) 888.4965
Submitted by: Sarah Lake Shippert
FDA Establishment # 1718903
Proposed Device:
| Tradename: | Tissu Trans Filtron Syringe Fill |
|---|---|
| Model/Product Number: | 3-TT-Filtron Syringe Fill |
| Common Name: | Suction Lipoplasty System |
| Classification name: | Suction Lipoplasty System |
| Product Code: | MUU |
| Regulation Number: | 21 CFR 878.5040 |
| Device: Class II, | Sterile |
| Submission Purpose: | Modification to: |
|---|---|
| Shippert Medical's Tissu Trans Filtron, K092482 | |
| Predicate Device: | Shippert Medical's Tissu Trans Filtron, K092482 |
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 or collection battles, calinoplasty Systems are classified as Class II. They have been assigned Product Code MUU.
Indications For Use
Tissu Trans Filtron Syringe Fill is intended to be used with house vacuum and/or cleared pumps, tubing and cannulas, for the collection of aspirated fat, for aesthetic cleared purilips, tubing and ournalias, for may be reinjected via a cleared injection apparatus.
1
con't. Section 19: 510(k) SUMMARY:
K102117
Intended Use: Shippert Medical's Tissu Trans Filtron Syringe Fill 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 Syringe Fill is used in the aspiration, harvesting, filtering and transferring of autologous tissue.
Tissue 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 .
- General Surgery ◆
- Orthopedic Surgery .
- Gynecological Surgery .
- Thoracic Surgery .
- Laparoscopic Surgery
The Indications For Use and the Intended Use are identical to the Predicate Device, Tissu Trans Filtron k0924.82.
Design Characteristics:
Tissu Trans Filtron Svringe Fill is an optional accessory to Shippert Medical's Tissu Trans Filtron, K092482. Shippert Medical's Tissu Trans Filtron Syringe Fill is a sterile, single use, disposable device used in the aspiration, harvest, filtering and transferring of autologous tissue. Used by physicians in the harvesting of body tissues, this device is a single use, disposable sterile canister with six enclosed 60cc syringes used for collecting the harvested tissue after harvesting/aspiration.. The harvested tissue is stored in the Syringe Fill syringes and is intended for immediate reinjection of the harvested tissue back into the donor patient.
Device Components:
The Tissu Trans Filtron Syringe Fill connects to the inverted Tissu Trans Filtron, K092482, with an accessory silicone tubing piece which is included in the Tissu Trans Filtron Syringe Fill packaging. This tubing is connected onto the the Tissu Trans Filtron Svringe Fill's lid at the appropriate in-take port. This same transfer tubing is then connected onto the inverted Tissu Trans Filtron at its out-take port. The vacuum tubing from the Tissu Trans Filtron is repositioned from the Tissu Trans Filtron's vacuum port to the Tissue Trans Filtron Syringe Fill's vacuum port. When the vacuum pump is turned
2
con't. Section 19: 510(k) SUMMARY:
on the Tissu Trans Filtron Syringe Fill's six syringes begin to fill up as the physician releases the pinch clamp. As one syringe is filled, the tissue continues to fill the subsequent svringes. A pinch clamp is used to close off the silicone transfer tubing after the final sixth syringe is filled and the vacuum pump is turned off. The physician or OR staff will remove the filled syringes and place a physician supplied FDA approved re-injection cannula onto the syringe's luer lock. The syringe's plunger will be inserted at the large open end of the syringe and re-injection of the autologous tissue can proceed.
Material Composition: The components of the Tissu Trans Filtron Syringe Fill do not have direct patient contact. The necessary FDA cleared liposuction cannula (direct patient contact) is supplied by the physician.
All components of the Tissu Trans Filtron Svringe Fill 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 Syringe Fill is sterilized by Gamma Radiation.
In Vitro Testing :
Clinical testing was conducted by Ronald D. Shippert, M.D. to validate and verify that the proposed device met all design specifications. Validation tests were conducted to validate the design control activity. Performance of the Tissu Trans Filtron Syringe Fill satisfies all design specifications. Mechanical testing of the Tissu Trans Filtron Syringe Fill 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 device.
Equivalence To Marketed Device:_Shippert Medical's Tissu Trans Filtron Syringe Fill is substantially equivalent to the Tissu Trans Filtron device under K092482. This new device is an optional accessory to the Shippert Medical Technologies Tissu Trans Filtron device.
Shippert Medical Technologies Tissu Trans Filtron K092482 Classification Name: Suction Lipoplasty System Class 2 Device, Product Code MUU Regulation Number 878.5040, General Hospital
3
con't. Section 19: 510(k) SUMMARY:
As stated in 21 CFR 878.5040 , (product code MUU), 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 2. They have been assigned Product Code MUU.
As 21 CFR 878.5040 states the existence of a "collection bottle and detachable tube" in the description of Product Code MUU, Shippert Medical is now modifying the original Tissu Trans Filtron, K092482 to offer an additional canister (collection bottle) and a detachable tube as an optional accessory.
Technological Characteristics: Shippert Tissu Trans Filtron Syringe Fill is used in conjunction with a hospital or facility supplied vacuum-powered body fluid suction apparatus which is capable of a low pressure setting of 15" of mercury. The Tissu Trans Filtron Syringe Fill is an optional accessory to the Tissu Trans Filtron, k 092482. The technological characteristics of the Tissu Trans Filtron Syringe Fill follow those of its predicate, Tissu Trans Filtron, K092482.
This device is sterilized by Gamma Radiaiton, same as the predicate device, K092482.
Summary: The Shippert Medical Tissu Trans Filtron Syringe Fill device described in this submission is a modification to the previously 510(k) cleared device. Tissu Trans Filtron K092482. This modification is substantially equivalent to the Tissu Trans Filtron K092482 predicate device and is safe and effective.
The modified device has the same classification, the same indications, the same intended use, the same fundamental technology, the same design structure as described in 878.5040, the same sterility protocol and the same safety and effectiveness performance as the predicate device.
Given the "Intended Use, Indications For Use, device technology, materials and basic design structure of Product Code MUU, Shippert Medical Technologies claim Substantial Equivalence to Tissu Trans Filtron, K092482.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized, curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Shippert Medical Technologies % Ms. Sarah Lake Shippert 6248 South Troy Circle, Unit A Centennial, Colorado 80111
Re: K102117
Trade/Device Name: Tissu Trans Filtron Syringe Fill Regulation Number: 21 CFR 878.5040 Regulation Name: Suction lipoplasty system Regulatory Class: Class II Product Code: MUU Dated: July 20, 2010 Received: July 28, 2010
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. 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.
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
AUG - 6 2010
5
Page 2 - Ms. Sarah Lake Shippert
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); 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,
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/Resourcesfor You/Industry/default.htm:
Sincerely yours.
cerely yours,
for
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known): K102117
AUG - 6 2010
Tissu Trans Filtron Syringe Fill Device Name:
Tissu Trans Filtron Syringe Fill 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.
X Prescription Use _ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR 807 Subpart C)
(Please DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel Krone for MXM
(Division Sign Off)
(Division Sign-Off) (Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K102117
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