(28 days)
This device is intended to clean the external ear canal and tympanum. The need to clear and clean the external ear canal.
Comprehensive, single use, sterile procedure pack comprising: 18 swg fine end 14 swg suction tube Cotton wool mop Wax curette
The provided document primarily consists of a 510(k) submission summary for the Exmoor Suction Clearance Kit and the FDA's clearance letter. It describes the device, its intended use, and its equivalence to predicate devices. However, this document does not contain information about specific acceptance criteria, a study that proves the device meets those criteria, or the detailed aspects of a performance study.
Therefore, I cannot provide detailed answers to most of your questions based only on the provided text. The document focuses on regulatory clearance based on substantial equivalence, rather than a clinical performance study with defined acceptance criteria and statistical analysis.
Here's what can be inferred or stated about the information requested, with clear indication of what is not present:
1. A table of acceptance criteria and the reported device performance
- Not provided. The document describes the device and its intended use but does not present a table of acceptance criteria (e.g., specific metrics for efficacy or safety) or reported performance against such criteria. The basis for clearance is substantial equivalence to legally marketed predicate devices, implying that their performance is considered acceptable.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided. This document does not detail any clinical test sets or studies with sample sizes.
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 provided. No information on experts or ground truth establishment for a test set is present.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not provided. No test set or adjudication method is described.
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
- Not provided. This device is an instrument kit (Ear Suction Clearance Kit), not an AI-assisted diagnostic tool. Therefore, an MRMC study with human readers and AI assistance is not applicable and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Not provided. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not provided. Since no specific performance study with a test set is detailed, the type of ground truth is not mentioned. The regulatory clearance is based on substantial equivalence to predicate devices, not on a new clinical ground truth establishment.
8. The sample size for the training set
- Not applicable/Not provided. This is a physical medical device. The concept of a "training set" is not relevant to its regulatory filing based on substantial equivalence.
9. How the ground truth for the training set was established
- Not applicable/Not provided. See point 8.
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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 (510K980828) |
| Description of Device: | Comprehensive, single use, sterile procedure packcomprising: 18 swg fine end14 swg suction tubeCotton wool mopWax curette |
| Intended Use: | This device is intended to clean the external earcanal and tympanum. |
| Comparison with PredicateDevices: | The component parts of this kit are present in boththe Exmoor Tympanocentesis Kit (510K 973587)and the Exmoor Myringotomy Kit (510K 980828).The Richards Ear Examkit is manufactured fromvery similar stainless steel and plastic, the maindifference being the inclusion of aural specula in theRichards kit. Exmoor considered these |
outpatients departments.
unnecessary, as they are standard equipment in
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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.
.
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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
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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)
§ 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.