(28 days)
Not Found
510K 973587, 510K 980828
No
The device description lists only manual tools and there is no mention of AI/ML or related concepts like image processing or performance metrics associated with algorithmic analysis.
No
The device is intended to clean the external ear canal and tympanum, which is a maintenance or hygiene function, not a therapeutic treatment for a disease or condition. Its purpose is to clear and clean, rather than to diagnose, cure, mitigate, treat, or prevent disease.
No
This device is described as being for cleaning the external ear canal and tympanum, which is a therapeutic or maintenance function, not a diagnostic one. It does not mention identifying, detecting, or measuring a condition or disease.
No
The device description explicitly lists physical components (suction tube, cotton wool mop, wax curette), indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "clean the external ear canal and tympanum." This is a physical cleaning procedure performed directly on the patient's body.
- Device Description: The components listed (suction tube, cotton wool mop, wax curette) are instruments used for physical manipulation and removal of material from the ear canal.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing samples (blood, urine, tissue, etc.) in vitro (outside the body).
- Detecting or measuring substances in samples.
- Providing information for diagnosis, monitoring, or treatment based on in vitro analysis.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information about a person's health. This device is a set of tools for a physical procedure.
N/A
Intended Use / Indications for Use
This device is intended to clean the external ear canal and tympanum.
The need to clear and clean the external ear canal.
Product codes
79 KDD, 77 LRC
Device Description
Comprehensive, single use, sterile procedure pack comprising: 18 swg fine end 14 swg suction tube Cotton wool mop Wax curette
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
external ear canal and tympanum
Indicated Patient Age Range
Not Found
Intended User / Care Setting
outpatients departments.
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)
Richards Ear Examkit, Exmoor Tympanocentesis Kit (510K 973587), Exmoor Myringotomy Kit (510K 980828)
Reference Device(s)
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/1 description: The image shows a dark background with some text. The text at the top appears to say "Attachment 1". The text at the bottom appears to say "DMR/LAL". The text is white and is in a sans-serif font.
Image /page/0/Picture/2 description: The image contains two logos. The logo on the left is a circular seal with the text "QUALITY ASSURED FIRM" around the top and "ISO 9001" in the center. Below the text is a check mark and the letters "SGS". The logo on the right has a crown at the top and a V-shaped symbol below it. Underneath the V-shaped symbol is the text "NATIONAL ACCREDITATION OF CERTIFICATION BODIES".
Image /page/0/Picture/3 description: The image shows the logo for Exmoor Plastics. The logo includes a drawing of a deer head with antlers, and the text "Exmoor Plastics" is written to the right of the deer head. Above the deer head, there is a handwritten date of 3/5/99.
Your Ref:
MB/PAS
Contact: Margaret Blackmore
Our Ref:
28 January 1999 Date:
Reference: DMR/1/1/64
SUMMARY OF SAFETY AND EFFECTIVENESS
| Trade Name: | Exmoor Suction Clearance Kit |
|---|---|
| Common Name: | Ear Suction Clearance Kit |
| Classification Name: | Surgical Instrument Kit, Disposable 79 KDD |
| Predicate Devices: | Richards Ear Examkit, Exmoor Tympanocentesis Kit |
| (510K 973587), Exmoor Myringotomy Kit (510K |
-
|
| Description of Device: | Comprehensive, single use, sterile procedure pack
comprising: 18 swg fine end
14 swg suction tube
Cotton wool mop
Wax curette |
| Intended Use: | This device is intended to clean the external ear
canal and tympanum. |
| Comparison with Predicate
Devices: | The component parts of this kit are present in both
the Exmoor Tympanocentesis Kit (510K 973587)
and the Exmoor Myringotomy Kit (510K 980828).
The Richards Ear Examkit is manufactured from
very similar stainless steel and plastic, the main
difference being the inclusion of aural specula in the
Richards kit. Exmoor considered these |
outpatients departments.
unnecessary, as they are standard equipment in
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 5 1999
Margaret Blackmore Regulatory Affairs Exmoor Plastic Ltd. Lisieux Way, Taunton, TA12LB,U.K.-United Kingdom
Re: K990366 Exmoor Suction Clearance Kit Regulatory Class: II/21 CFR 874.4420 Product Code: 77 LRC Dated: January 29, 1999 Received: February 5, 1999
Dear Ms. 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 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). 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 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 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 regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification 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.
.
2
Page 2 -- Margaret Blackmore
If 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/dsma/dsmamain.html".
be the country of the county of the a proved for are and super . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Sincerely yours,
M
David W. Seymon
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health idiological Heal
3
510(k) Number (if known): 190364
EXMOOR SUCTION CLEARANCE KIT Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications for Use:
: 【
The need to clear and clean the external ear canal.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Third G. Seegm
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K990366
Prescription Use √
(Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)