EXMOOR TYMPANOCENTESIS KIT (TK/1)

K973587 · Exmoor Plastics , Ltd. · JZF · Jan 23, 1998 · Ear, Nose, Throat

Device Facts

• Record ID: K973587
• Device Name: EXMOOR TYMPANOCENTESIS KIT (TK/1)
• Applicant: Exmoor Plastics , Ltd.
• Product Code: JZF · Ear, Nose, Throat
• Decision Date: Jan 23, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4420
• Device Class: Class 1

Indications for Use

This device is intended to collect middle ear fluid within the viscosity range of sae 30-50 for laboratory analysis.

Device Story

Single-use kit for collecting middle ear fluid samples. Components include myringotome for tympanic membrane puncture, aspirating suction tube, aural speculum, vial assembly, and various procedural accessories (drape, gloves, disposal bag). Used by clinicians to obtain fluid samples for laboratory analysis. Device facilitates diagnosis by enabling fluid collection from behind intact eardrum. Sterilized by gamma irradiation.

Clinical Evidence

bench testing only

Technological Characteristics

Single-use kit. Components: myringotome, suction tube, aural speculum (2.5mm), vial assembly, surgical drape, gloves, disposal bags. Sterilization: gamma irradiation. No electronic or software components.

Indications for Use

Indicated for the aspiration and analysis of middle ear fluid from behind an intact tympanic membrane (ear drum).

Regulatory Classification

Identification

An ear, nose, and throat manual surgical instrument is one of a variety of devices intended for use in surgical procedures to examine or treat the bronchus, esophagus, trachea, larynx, pharynx, nasal and paranasal sinus, or ear. This generic type of device includes the esophageal dilator; tracheal bistour (a long, narrow surgical knife); tracheal dilator; tracheal hook; laryngeal injection set; laryngeal knife; laryngeal saw; laryngeal trocar; laryngectomy tube; adenoid curette; adenotome; metal tongue depressor; mouth gag; oral screw; salpingeal curette; tonsillectome; tonsil guillotine; tonsil screw; tonsil snare; tonsil suction tube; tonsil suturing hook; antom reforator; ethmoid curette; frontal sinus-rasp; nasal curette; nasal rasp; nasal rongeur; nasal saw; nasal scissors; nasal snare; sinus irrigator; sinus trephine; ear curette; ear excavator; ear rasp; ear scissor, ear snare; ear spoon; ear suction tube; malleous ripper; mastoid gauge; microsurgical ear chisel; myringotomy tube inserter; ossici holding clamp; sacculotomy tack inserter; vein press; wire ear loop; microrule; mirror; mobilizer; ear, nose, and throat punch; ear, nose and throat knife; and ear, nose, and throat trocar.

Predicate Devices

• Xomed, Juhn Tym-Tap (14-19010)
• Sherwood, Specimen Trap (8884-724500)
• Storz, Senturia Specimen Collectors (NO600/NO601)
• Storz, Alden-Senturia Specimen Collector (N0605)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows a logo with a deer head on the left and the word "Exmoor Plastics" on the right. The deer head is drawn in black and white and has large antlers. The text is in a bold, sans-serif font, with "Exmoor" on the top line and "Plastics" on the bottom line.

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8

moor

K973587

Jan 23 1998

| Your Ref: | |
|-----------|--------------------|
| Our Ref: | MB/PAS/DMR/1/H/48 |
| | 10 November 1997 |
| Contact: | Margaret Blackmore |
| Ref: | K.973587 |

Summary of Safety and Effectiveness

| Trade Name: | Exmoor Tympanocentesis Kit |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Tympanocentesis Kit |
| Classification Name: | Tube, Ear, Suction |
| Predicate Devices: | Xomed, Juhn Tym-Tap (ref. 14-19010)<br>Sherwood, Specimen Trap (ref. 8884-724500)<br>Storz, Senturia Specimen Collectors (ref. NO600/NO601)<br>Storz, Alden-Senturia Specimen Collector (ref. N0605) |
| Description of Device: | This single use device is designed to collect<br>specimens of middle ear fluid from behind an intact<br>tympanic membrane and comprises the following: |
| | polythene disposal bag<br>glove (examination)<br>'Disposafe' (for sharps)<br>fenestrated surgical ear drape<br>mop<br>label<br>vial assembly<br>suction tube (hand-piece)<br>myringotome (aspirating)<br>specimen bag (laboratory)<br>aural speculum, 2.5mm |

It has been sterilized by gamma irradiation and is
ready for use.

| Intemded Use: | This device is intended to collect middle ear fluid<br>within the viscosity range of sae 30-50 for<br>laboratory analysis. |
|---------------|----------------------------------------------------------------------------------------------------------------------------|
|---------------|----------------------------------------------------------------------------------------------------------------------------|

Exmoor Plastics Ltd., Lisieux Way, Taunton, TA1 2LB, U.K.

T | [phone]

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Comparison with Predicate Devices:

- 1. Juhn Tym-Tap, (ref. 14-19010), manufactured by Xomed, is similar, but does not feature a myringotome to puncture the tympanum. It is disposable. Catalogue entry enclosed.
- The 40cc Specimen Trap (ref. 8884-724500). 2. Sherwood, has neither manufactured by myringotome, nor micro-bore suction tubing. It is disposable. Picture enclosed.
- Senturia 3. Collector (N0605), manufactured by Storz. These are reusable. Catalogue entry enclosed.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized representation of a human figure in profile, composed of three overlapping shapes. The figure is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a sans-serif font. The text is arranged around the upper half of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 3 1998

Margaret Blackmore Regulatory Affairs Exmoor Plastics Ltd. Lisieux Way, Taunton TA1 2LB, U.K.

Re: K973587 Trade Name: TK/1 Tympanocentesis Kit Regulatory Class: I/21 CFR 874.4420 Product Code: 77 JZF Dated: November 25, 1997 December 1, 1997 Received:

Dear Mr. Blackmore:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is 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, Druq, and Cosmetic Act (Act) . . You may, therefore, market the device, subject to the general controls provisions of the Act. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510 (k) before including these components in your kit. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) 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 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 QS inspections, FDA will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, the Food and Drug Administration (FDA) may publish further

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## Page 2 - Margaret Blackmore

announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission 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.

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

David G. Styrman
Lillian Yin, Ph.D.

Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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ATTACHMENT 1

RAM/19/A/1

Device Listing Number: A895746 510(k) Number (if known):_ K 9 33 8

Device Name: Exmoor Tympanocentesis Kit

Indications for Use:

Requirement for aspiration and analysis of middle ear fluid from behind an intact tympanic membrane (ear drum)

(Please Do not WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David L. Yocom

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Device 510(k) Number

Prescription Use_ (Per 21 CFR 801.109) OR

Over-The-Counter Use_

(Optional Format 1-2-96)