PENCIL-GRIP FNA SYRINGE HOLDER AND EFFORTLESS NEEDLE REMOVER

K972496 · Tao & Tao Technologyt, Inc. · KNW · Dec 9, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K972496
• Device Name: PENCIL-GRIP FNA SYRINGE HOLDER AND EFFORTLESS NEEDLE REMOVER
• Applicant: Tao & Tao Technologyt, Inc.
• Product Code: KNW · Gastroenterology, Urology
• Decision Date: Dec 9, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1075
• Device Class: Class 2

Intended Use

The TAO ASPIRATORTM is a device to hold a 10cc syringe for performing fine needle aspiration of a palpable mass with one hand, while stabilizing the mass to be aspirated with the other hand. It is equipped with a release button for automatically drawing back the syringe plunger, and is designed to be held in a pencil-grip manner. This device places the hand relatively close to the needle tip while the hand is in a position of natural function, enabling the needle movement using fine motor control of the hand. The PLASTIC FINGERTM is an accessory to the TAO ASPIRATORTM to facilitate specimen procurement. It facilitates needle removal so that air can be drawn into the syringe, and the aspirated material in the needle and needle hub can then be expressed onto slides. It can also be used to grip slides for fixation and staining.

Device Story

The TAO ASPIRATOR is a manual, pencil-grip device designed to hold a 10cc syringe for fine needle aspiration of palpable masses. It allows one-handed operation, enabling the clinician to stabilize the mass with the other hand. The device features a release button that automatically draws back the syringe plunger to create suction. The PLASTIC FINGER is an accessory used to assist in needle removal, drawing air into the syringe to express aspirated material onto slides, and gripping slides during fixation and staining. The system is intended for use in clinical settings by healthcare professionals to improve fine motor control and specimen procurement during aspiration procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Manual, mechanical syringe-holding device. Pencil-grip form factor. Includes a release button mechanism for plunger retraction. Plastic construction.

Indications for Use

Indicated for fine needle aspiration of palpable masses. Used by clinicians to hold a 10cc syringe and stabilize masses during aspiration procedures.

Regulatory Classification

Identification

A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 9 1997

Ms. Pauline Tao General Manager TAO & TAO Technology, Incorporated 957 Ashton Place Carmel, Indiana 46033

Re: K972496

Trade Name: TAO ASPIRATOR™ and PLASTIC FINGER™ Regulatory Class: II Product Code: KNW Dated: September 29, 1997 Received: October 1, 1997

Dear Ms. Tao:

We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. In addition, FDA may publish further announcements concerning your devices in the Federal Register. Please note: this response to your premarket notification submissions does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Tao

This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market.

If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your devices, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours,

toseefer

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## 510(K) Number: K972496 Device Name: TAO ASPIRATORTM and PLASTIC FINGERTM

## INDICATIONS FOR USE:

The TAO ASPIRATORTM is a device to hold a 10cc syringe for performing fine needle aspiration of a palpable mass with one hand, while stabilizing the mass to be aspirated with the other hand. It is equipped with a release button for automatically drawing back the syringe plunger, and is designed to be held in a pencil-grip manner. This device places the hand relatively close to the needle tip while the hand is in a position of natural function, enabling the needle movement using fine motor control of the hand.

The PLASTIC FINGERTM is an accessory to the TAO ASPIRATORTM to facilitate specimen procurement. It facilitates needle removal so that air can be drawn into the syringe, and the aspirated material in the needle and needle hub can then be expressed onto slides. It can also be used to grip slides for fixation and staining.

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|-----------------------------------------|---------|
| Division of General Restorative Devices | |
| 510(k) Number | K972496 |

| Prescription Use | <div style="display:inline-block; vertical-align:middle;">X</div> |
|----------------------|-------------------------------------------------------------------|
| (Per 21 CFR 801.109) | |

OR

| Over-The-Counter Use | |
|----------------------|--|
|----------------------|--|

(Optional Format 1-2-96)