(123 days)
Not Found
Not Found
No
The device description and intended use focus on a mechanical collection system for middle ear fluid and do not mention any computational or analytical capabilities that would suggest the use of AI or ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device is intended to collect middle ear fluid for laboratory analysis, which is a diagnostic purpose, not a therapeutic one.
No
This device is designed to collect middle ear fluid for laboratory analysis, not to perform the analysis itself or provide a diagnosis. It is a specimen collection device.
No
The device description clearly lists multiple physical components (polythene disposal bag, glove, 'Disposafe', surgical ear drape, mop, label, vial assembly, suction tube, myringotome, specimen bag, aural speculum) and states it is sterilized by gamma irradiation, indicating it is a physical medical device, not software-only.
Based on the provided information, this device is likely an IVD (In Vitro Diagnostic) device component or accessory.
Here's why:
- Intended Use: The device's primary purpose is to collect middle ear fluid for laboratory analysis. This directly aligns with the definition of an IVD, which involves examining specimens derived from the human body to provide information for diagnostic purposes.
- Device Description: The device is a collection kit containing various components specifically designed for obtaining a biological specimen (middle ear fluid).
- Lack of Direct Diagnostic Function: The device itself does not perform the analysis or provide a diagnosis. It is a tool for obtaining the sample that will be used in an in vitro diagnostic procedure.
Therefore, while the device itself isn't the diagnostic test, it is an essential part of the IVD process by providing the specimen for analysis. It would likely be classified as an IVD accessory or component.
N/A
Intended Use / Indications for Use
This device is intended to collect middle ear fluid within the viscosity range of sae 30-50 for laboratory analysis.
Requirement for aspiration and analysis of middle ear fluid from behind an intact tympanic membrane (ear drum)
Product codes (comma separated list FDA assigned to the subject device)
77 JZF
Device Description
This single use device is designed to collect specimens of middle ear fluid from behind an intact tympanic membrane and comprises the following: polythene disposal bag glove (examination) 'Disposafe' (for sharps) fenestrated surgical ear drape mop label vial assembly suction tube (hand-piece) myringotome (aspirating) specimen bag (laboratory) aural speculum, 2.5mm
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
middle ear, tympanic membrane
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.
Not Found
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
§ 874.4420 Ear, nose, and throat manual surgical instrument.
(a)
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.(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 § 874.9.
0
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.
- 201
8
moor
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) |
| Sherwood, Specimen Trap (ref. 8884-724500) | |
| Storz, Senturia Specimen Collectors (ref. NO600/NO601) | |
| Storz, Alden-Senturia Specimen Collector (ref. N0605) | |
| Description of Device: | This single use device is designed to collect |
| specimens of middle ear fluid from behind an intact | |
| tympanic membrane and comprises the following: | |
| polythene disposal bag | |
| glove (examination) | |
| 'Disposafe' (for sharps) | |
| fenestrated surgical ear drape | |
| mop | |
| label | |
| vial assembly | |
| suction tube (hand-piece) | |
| myringotome (aspirating) | |
| specimen bag (laboratory) | |
| 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
within the viscosity range of sae 30-50 for
laboratory analysis. |
| --------------- | ---------------------------------------------------------------------------------------------------------------------------- |
|---|
Exmoor Plastics Ltd., Lisieux Way, Taunton, TA1 2LB, U.K.
T | (01000) 070007
1
Comparison with Predicate Devices:
-
- 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.
2
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
3
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 (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597, 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
4
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)