TISSU-TRANS

K050797 · Shippert Medical Technologies Corp. · KYZ · Jul 13, 2005 · General Hospital

Device Facts

• Record ID: K050797
• Device Name: TISSU-TRANS
• Applicant: Shippert Medical Technologies Corp.
• Product Code: KYZ · General Hospital
• Decision Date: Jul 13, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6960
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

Tissu-Trans™ is intended to be used when harvesting, filtering and transferring of autologous fat is desired.

Device Story

Tissu-Trans™ is a sterile, single-use, disposable piston syringe system for autologous fat harvesting, filtering, and transfer. The device consists of a 10cc syringe with a Luer Lock tip and barrel perforations, housed within a 60cc outer barrel connected to an aspiration machine. During operation, fat is collected into the 10cc syringe; waste products are strained through the barrel holes into the 60cc outer tube and suctioned into a waste container. The 10cc syringe is then removed, fitted with a sleeve, and used for direct re-injection. Used by physicians in clinical settings, the device maintains the fat in a sterile field, reducing handling, trauma, and contamination risk compared to traditional methods involving centrifugation and washing. This streamlined process minimizes time outside the body and preserves fat cell viability for re-injection.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Piston syringe system; 10cc syringe with Luer Lock tip and barrel perforations; 60cc outer barrel housing; medical-grade tubing; manual/suction-assisted operation; sterile, single-use, disposable; non-powered (uses external aspiration machine).

Indications for Use

Indicated for aspiration harvesting, filtering, and transferring of autologous tissue in patients undergoing fat grafting procedures.

Regulatory Classification

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.

Predicate Devices

• Johnson & Johnson Syringe (K884749)
• LipiVage (no 510(k) number provided)

Submission Summary (Full Text)

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**Shippert** Medical Technologies K055797

Jhe Denver Splint Company

JUL 1 3 2005

6248 S. Troy Circle, Unit A Centennial, CO 80111 Telephone [phone] [phone] Facsimile 1-800-284-0864 [phone] 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: [phone] Contact: Sarah Lake Email: [e-mail]

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.

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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.

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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.

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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 [phone]. 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 [phone] or [phone] 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

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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