(106 days)
k)884749
Not Found
No
The device description details a mechanical syringe system for fat transfer and does not mention any software, algorithms, or data processing that would indicate AI/ML.
No
The device is described as a piston syringe for harvesting, filtering, and transferring autologous fat, which is a procedural tool rather than a device intended to treat or cure a disease or condition.
No
The device is described as a piston syringe used for harvesting, filtering, and transferring autologous fat for re-injection, which are interventional procedures, not diagnostic ones.
No
The device description clearly describes a physical syringe device with mechanical components (piston, barrel, tubing, holes) used for harvesting, filtering, and transferring fat. There is no mention of any software component.
Based on the provided information, the Tissu-Trans™ device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is for harvesting, filtering, and transferring autologous fat within the body (re-injection into the patient). This is a surgical/procedural device, not a device used to examine specimens outside the body to provide diagnostic information.
- Device Description: The description details a syringe system for collecting and processing tissue (fat) for re-implantation. It does not describe any components or functions related to analyzing biological samples for diagnostic purposes.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing blood, urine, tissue samples, etc.
- Providing diagnostic information about a patient's health status.
- Using reagents or assays.
- Measuring analytes.
The Tissu-Trans™ is clearly described as a device used in a surgical procedure involving the manipulation and transfer of tissue within the patient's body.
N/A
Intended Use / Indications for Use
Tissu-Trans™ is intended to be used when harvesting, filtering and transferring of autologous fat is desired.
Tissu-Trans™ is a piston syringe used in the aspiration harvesting, filtering and transferring of autologous tissue.
Product codes (comma separated list FDA assigned to the subject device)
KYZ
Device Description
Tissue-Trans™ is a sterile, single use, disposable syringe device used in the harvesting, filtering and transferring of autologous fat. Used by acinso asounding procedures,Tissue Trans™ simplifies and reduces the steps prysiolane in the collection and transfer of the autologous fat. In so doing, the harvested fat is less traumatized and risk of contamination is lowered because the fat never leaves the harvesting syringe until re-injection.
Tissu-Trans™ is a piston syringe device comprised of a small 10cc syringe with Luer Lock tip that has small holes drilled into its barrel. This small10cc syringe is placed inside a larger 60cc barrel type tube, which is attached to a medical grade tubing and aspiration machine. As the autologous fat is collected into the 10cc syringe, the waste products are strained through the holes in the 10cc syringe into the large 60cc barrel tube and suctioned into a waste container. The small syringe is removed from the large 60cc tube, a sleeve is attached to the small 10cc syringe around the barrel and the autologous fat is re-injected into the patient at desired locations.
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.
k)884749
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
§ 880.6960 Irrigating syringe.
(a)
Identification. An irrigating syringe is a device intended for medical purposes that consists of a bulb or a piston syringe with an integral or a detachable tube. The device is used to irrigate, withdraw fluid from, or instill fluid into, a body cavity or wound.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. If the device is not labeled or otherwise represented as sterile, it is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.
0
Shippert Medical Technologies K055797
Jhe Denver Splint Company
JUL 1 3 2005
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 www.shippertmedical.com Website
510(k) SUMMARY Section 3:
Date: March 16, 2005
1:2
Name: Shippert Medical Technologies 6248 South Troy Circle, Unit A Centennial, Colorado 80111 · Tele: 303.754.0044 Fax: 303.754.0318 Contact: Sarah Lake Email: sarah@shippertmedical.com
Tradename: Common Name: Classification name: Product Code: Requlation Number: Class I Sterile
Tissu-Trans™ Syringe, irrigating Syringe, irrigating (Non-Dental) KYZ 21 CFR 880.6960
Substantial Equivalence:_Shippert Medical is requesting a claim of substantial equivalence to two devices as listed under Product Code KYZ. We can only find one of these devices 510(k) number. See below.
Shippert Medical is requesting a claim of Substantial Equivalence to the device Classification Name: Syringe, Irrigating Johnson & Johnson Syringe, (k)884749 (Non-Dental), Class I Device, Product Code KYZ, Regulation Number 880.6960, General Hospital. See Section 7 for Substantial Equivalence data, Exhibit E.
Shippert Medical is requesting a claim of substantial equivalence to the product "LipiVage" manufactured and marketed by Genesis Biosystems. "LipiVage" is a sterile, disposable syringe FDA listed device by Genesis Biosystems under Product Scille, Classification name: Syringe, Irrigating (Non-Dental), Class I Device, Product Code KYZ, Regulation Number 880.6960, General Hospital. I have been r round of ocate their 510(k) number for LipiVage. See Section 7 for Substantial Equivalence data, Exhibit F.
Description of the Device: Tissue-Trans™ is a sterile, single use, disposable syringe device used in the harvesting, filtering and transferr ing of autologous fat. Used by acinso asounding procedures,Tissue Trans™ simplifies and reduces the steps prysiolane in the collection and transfer of the autologous fat. In so doing, the harvested fat is less traumatized and risk of contamination is lowered because the fat never leaves the harvesting syringe until re-injection.
1
Shippert Medical Technologies 510k Application - Tissu-Trans™ March 16, 2005
k 05079
510(k) SUMMARY, con't. Section 3: ___________________________________________________________________________________________________________________________________________________________________
page 2:2
Intended Use; Tissu-Trans™ is intended to be used when harvesting, filtering and transferring of autologous fat is desired.
Technological Characteristics: Tissu-Trans™ is a piston syringe device comprised of a small 10cc syringe with Luer Lock tip that has small holes drilled into its barrel. This small10cc syringe is placed inside a larger 60cc barrel type tube, which is attached to a medical grade tubing and aspiration machine. As the autologous fat is collected into the 10cc syringe, the waste products are strained through the holes in the 10cc syringe into the large 60cc barrel tube and suctioned into a waste container. The small syringe is removed from the large 60cc tube, a sleeve is attached to the small 10cc syringe around the barrel and the autologous fat is re-injected into the patient at desired locations.
Previous procedure technology demanded the aspiration, washing, centrifuging and re-injection of the then over-handled fat cells. Tissu-Trans™, like LipiVage, decreases the number of steps a physician must take to process the fat for re-injection. The fat remains in a sterile field at all times with Tissu-Trans™, thus reducing the risk of infection. The fat cells also are less traumatized due to the low vacuum levels, no centrifuging, less time outside of the body, and the fewer numbers of harvesting, washing, filtering and transfer steps.
Summary: The Tissu-Trans™ device described in this submission is substantially equivalent to the predicate devices, and is safe and effective.
The device design and materials used, are similar to those of the Predicate Device Johnson & Johnson Syringe K884749 and LipiVage, k# unknown, and also to most of the piston syringes in the Product Code KYZ.
As stated in CFR 880.6960, (product code KYZ) "An irrigating syringe is a device intended for medical purposes that consists of a bulb or piston syringe with integral or a detachable tube. The device is used to irrigate, withdraw fluid from, or instill fluid into, a body cavity or wound."
Given the "Intended Use" and basic design structure of Product Code KYZ, Shippert Medical Technologies claims Substantial Equivalence to the above listed devices. Even given the Class I Exempt Device Status of Product Code KYZ, due to our product's sterile state, we are submitting a 510(k) Premarket Submission.
2
Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half of the circle. Inside the circle is an emblem of an eagle with its wings spread, with three horizontal lines above the eagle's head.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 3 2005
Ms. Sarah M. Lake Regulatory Affairs Shippert Medical Technologies 6248 S. Troy Circle, Unit A Centennial, Colorado 80111
Re: K050797
Trade/Device Name: Tissu-Trans™ Regulation Number: 21 CFR 880.6960 Regulation Name: Irrigating Syringe Regulatory Class: I Product Code: KYZ Dated: June 15, 2005 Received: June 17, 2005
Dear Ms. Lake:
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 such 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); 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.
3
Page 2 - Ms. Sarah M. Lake
This letter will allow you to begin marketing your device as described in your Section 510(k) I mo letter will and the FDA finding of substantial equivalence of your device to a legally premated predicate device results in a classification for your device and thus, permits your device 1. 1. 1. 1. 1. to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please it you active of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general michinal and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Zeth
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Shippert Medical Technologies 510k Application - Tissu-Trans™ March 16, 2005
050797
Section 2: STATEMENT OF INDICATIONS FOR USE
510k Number if known: _K 050 747
Device Name: Tissu-Trans™
Indications for Use:
Tissu-Trans™ is a piston syringe used in the aspiration harvesting, filtering and transferring of autologous tissue.
(Division Sign-Off) Division of General, Restorative and Neurological Devices
Number K050797