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.

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.

AI/ML Overview

The provided document is a 510(k) summary for a medical device called Tissu-Trans™ by Shippert Medical Technologies. It focuses on demonstrating substantial equivalence to existing devices rather than presenting a performance study with detailed acceptance criteria and results. Therefore, much of the requested information regarding acceptance criteria, study design, and performance metrics for the device itself is not available in this type of submission.

Here's an attempt to answer the questions based on the provided text, while also noting what information is not available in this type of regulatory document.

Explanation of the Submission Type:
A 510(k) premarket notification is submitted to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device. This process often relies on comparisons of technological characteristics, intended use, and materials to show that the new device is as safe and effective as the predicate. It does not typically require extensive clinical trials or performance studies with detailed acceptance criteria and ground truth validation for the new device as would be seen for novel technologies or higher-risk devices.

Acceptance Criteria and Study Details for Shippert Medical Technologies Tissu-Trans™

Given the nature of a 510(k) premarket notification, the "acceptance criteria" for the device itself in terms of specific performance metrics (like accuracy, sensitivity, specificity, or error rates) are not explicitly stated or demonstrated through a formal performance study with a test set, ground truth, or expert adjudication as one might see for an AI/CAD system. Instead, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to predicate devices. This means that if the new device has similar technological characteristics, intended use, and materials to a legally marketed predicate, it is deemed acceptably safe and effective.

The study that "proves" the device meets these criteria is primarily the comparison to predicate devices described in the 510(k) submission.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied for 510(k) Substantial Equivalence)	Reported Device Performance / Justification
Intended Use Equivalence: The device's intended use is substantially similar to predicate devices.	Tissu-Trans™ Intended Use: "harvesting, filtering and transferring of autologous fat."Predicate Equivalence: This is deemed equivalent to the intended use of the predicate devices based on the product code KYZ description: "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."
Technological Characteristics Equivalence: The device has similar technological characteristics to predicate devices.	Tissu-Trans™ Characteristics: "piston syringe device comprised of a small 10cc syringe with Luer Lock tip that has small holes drilled into its barrel. This small 10cc syringe is placed inside a larger 60cc barrel type tube..." Predicate Equivalence: "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." The mechanism for separating fat from waste products is described as an improvement due to "less traumatized" fat cells and "reduced risk of infection" due to remaining in a sterile field.
Materials Equivalence: Materials used are safe and similar to predicate devices.	Tissu-Trans™ Materials: Implied to be medical-grade and similar to "most of the piston syringes in the Product Code KYZ." (Specific material details are not provided in this summary but would be in the full submission).
Safety and Effectiveness: The device is as safe and effective as the predicate devices.	Conclusion: "The Tissu-Trans™ device described in this submission is substantially equivalent to the predicate devices, and is safe and effective." This is a declarative statement based on the comparison rather than a result of a direct performance study.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable / Not Provided: For a 510(k) submission based on substantial equivalence to an existing device, there isn't typically a "test set" in the sense of a dataset used to validate performance metrics like accuracy or error rates for the new device. The "test" is the comparison to the predicate device's design, materials, and intended use. No specific data provenance (country, retrospective/prospective) is relevant to this type of comparison.

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)

Not Applicable / Not Provided: As there is no "test set" with performance metrics requiring ground truth in this 510(k) summary, no experts were involved in establishing ground truth for a performance study of the Tissu-Trans™ device. The FDA reviews the provided information to determine substantial equivalence.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable / None: No adjudication method was used for a test set, as no such performance study is described in this 510(k) summary.

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: This is not an AI/CAD device. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed or is relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No: This is not an AI/CAD device. Therefore, no standalone algorithm performance study was done.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not Applicable / None: No ground truth was established for a performance study of the Tissu-Trans™ device itself. The "ground truth" for a 510(k) is effectively the established safety and effectiveness of the predicate device(s).

8. The sample size for the training set

Not Applicable / None: This is not a machine learning or AI device that would require a training set.

9. How the ground truth for the training set was established

Not Applicable / None: As there is no training set for this device, no ground truth was established for it.

Summary

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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 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.

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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 (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

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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

Regulation Number and Section

§ 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.