(212 days)
The MAHE Pediatric Naso-Pharyngoscope is intended for use only by qualified surgeons. Do not use the instrument for any purpose other than its intended application.
The MAHE Pediatric Naso-Pharyngoscope has been designed to be used with a light source, documentation equipment and video monitor for sinuscopy diagnosis and treatment within the nasal cavity and nasal pharynx.
The MAHE Pediatric Naso-Pharyngoscope is indicated for visual exam during diagnostic and therapeutic procedure within the nasal cavity and nasal pharynx.
The MAHE International Pediatric NASOPHARYNGOSCOPE is indicated for visual examination during a diagnostic and therapeutic procedure within the nasal cavity and nasal pharynx.
The MAHE Pediatric Naso-Pharyngoscope has been designed to be used with a light source, documentation equipment and video monitor for sinuscopy diagnosis and treatment within the nasal cavity and nasal pharynx.
The provided text is a 510(k) summary for the MAHE Pediatric Naso-Pharyngoscope, and as such, it focuses on demonstrating substantial equivalence to a predicate device rather than conducting a detailed clinical study with acceptance criteria, ground truth establishment, or specific performance metrics in the way a new diagnostic algorithm might.
Therefore, many of the requested categories are not applicable or not explicitly stated in this type of regulatory submission.
Here's an analysis based on the provided text:
Acceptance Criteria and Study for MAHE Pediatric Naso-Pharyngoscope:
The device's acceptance is based on demonstrating substantial equivalence to a predicate device (KARL STORZ NASOPHARYNGOSCOPE K945381). This means that the new device does not incorporate any significant change in intended use, method of operation, material, or design that could affect safety or effectiveness compared to the predicate. The "study" in this context is the comparison against the predicate device's specifications and the adherence to voluntary safety standards.
1. Table of Acceptance Criteria and Reported Device Performance:
| Feature (Acceptance Criteria implicitly based on predicate or safety standards) | New Device Performance (Reported) | Predicate Device Performance |
|---|---|---|
| Optical System | ||
| Field of view | 95 degree | 80+/-4 degree |
| Depth of view | 3-50mm | 3-50mm |
| Working length | 300-420mm | 320mm |
| Sheath | ||
| Shaft | 2.7mm | 2.7 mm |
| Distal end | 2.8mm | 2.8 mm |
| Material | Identical | Identical |
| Bending Section | ||
| Up | 120 | 160+3,-10 |
| Down | 100 | 130 +5,-10 |
| Sterilization Method(s) | (Not specified, but expected to be compatible) | (Not specified) |
| Weight | not more than 0.8 kg | .5-.7 kg |
Acceptance Criteria Met by the Study:
The "study" presented is a direct comparison of physical and functional characteristics to a legally marketed predicate device. The implicit acceptance criterion is that the new device's specifications are either identical to, or within a range considered safe and effective compared to, the predicate, without introducing new safety or effectiveness concerns. The provided table demonstrates that for most critical dimensions (e.g., shaft, distal end, depth of view, material), the new device is identical or very similar. While some parameters like "Field of view" and "Bending Section" show differences, the FDA's clearance (K030857) implies these differences were deemed not to affect safety or effectiveness negatively for the stated indications. Adherence to Voluntary Safety Standards IEC 601-1 and IEC 601-2-18 is also stated as an acceptance criterion.
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not applicable. This is not a study involving patient data or a test set in the traditional sense of evaluating an algorithm's performance on a dataset. It's a comparison of device specifications.
- Data Provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth for a test set is not established in this type of submission. The "ground truth" for substantial equivalence is the predicate device's established safety and effectiveness.
4. Adjudication method for the test set:
- Not applicable.
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 applicable. This device is an instrument, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable.
7. The type of ground truth used:
- The "ground truth" in 510(k) for devices like this is the established safety and effectiveness of the legally marketed predicate device and adherence to relevant voluntary safety standards (IEC 601-1 and IEC 601-2-18).
8. The sample size for the training set:
- Not applicable. This is not a machine learning or algorithm-based device.
9. How the ground truth for the training set was established:
- Not applicable.
{0}------------------------------------------------
030857
OCT 1 6 2003
510 (k) Summary of Safety and Effectiveness
| DEVICE NAME: | MAHE Pediatric Naso Pharyngoscope its associated and ancillary equipment and endoscopic accessories |
|---|---|
| COMMON/USUAL NAME | Pediatric Naso-Pharyngoscope and Accessories |
| CLASSIFICATION NAME | Pediatric Naso-Pharyngoscope and Accessories |
| PREDICATE DEVICES | KARL STORZ NASOPHARYNGOSCOPE (FLEXIBLE OR RIGID) K945381 |
| SUBMITTED BY: | Paul CartMAHE International Inc490 Craighead StNashville, TN 37204615-269-7256 |
| ESTABLISHMENT # | 9007726 |
The MAHE Pediatric Naso-Pharyngoscope is intended for use only by qualified surgeons. Do not use the instrument for any purpose other than its intended application.
The MAHE Pediatric Naso-Pharyngoscope has been designed to be used with a light source, documentation equipment and video monitor for sinuscopy diagnosis and treatment within the nasal cavity and nasal pharynx.
The MAHE Pediatric Naso-Pharyngoscope is indicated for visual exam during diagnostic and therapeutic procedure within the nasal cavity and nasal pharynx.
The MAHE Pediatric Naso-Pharyngoscope are designed, manufactured, and tested according to Voluntary Safety Standards IEC 601-1 and IEC 601-2-18.
When compared with the predicate devices, the MAHE Pediatric Naso-Pharyngoscope does not incorporate any significant change in intended use, method of operation, material, or design that could affect the safety or effectiveness.
Only physicians who have received thorough previous training in the art of flexible sinuscopy should use this instrument.
{1}------------------------------------------------
Predicate Device Comparison
| Feature | New Device | Predicate |
|---|---|---|
| Optical System | ||
| Field of view | 95 degree | 80+/-4 degree |
| Depth of view | 3-50mm | 3-50mm |
| Working length | 300-420mm | 320mm |
| Sheath | ||
| Shaft | 2.7mm | 2.7 mm |
| Distal end | 2.8mm | 2.8 mm |
| Material | Identical | Identical |
| Bending Section | ||
| Up | 120 | 160+3,-10 |
| Down | 100 | 130 +5,-10 |
| Sterilization Method(s) | ||
| Weight | not more than 0.8 kg | .5-.7 kg |
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized symbol that resembles three human profiles facing to the right, with flowing lines suggesting movement or connection.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 6 2003
MAHE International, Inc. c/o Paul Cart 490 Craighead Nashville, TN 37204
Re: K030857
Trade/Device Name: MAHE Pediatric Naso Pharyngoscope its associated and Ancillary equipment and endoscopic accessories Regulation Number: 21 CFR 874.4760 Regulation Name: Nasopharyngoscope (flexible or rigid) and accessories Regulatory Class: Class II Product Code: EOB Dated: September 24, 2003 Received: September 24, 2003
Dear Mr. Cart:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, 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 device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
{3}------------------------------------------------
Page 2 - Paul Cart
This letter will allow you to begin marketing your device as described in your Section 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer 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
Sincerely vours.
A. Károlyi Károly
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
STATEMENT FOR INDICATIONS FOR USE
510 (k) Number :
Device Name: MAHE International Pediatric NASOPHARYNGOSCOPE
Indications for Use:
The MAHE International Pediatric NASOPHARYNGOSCOPE is indicated for visual examination during a diagnostic and therapeutic procedure within the nasal cavity and nasal pharynx.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRD, Office of Device Evaluation (ODE)
Karin Bohm
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, And Radiological Devices
510(k) Number: K03083
OR Over-the-Counter Use:_ Prescription Use: (Per 21 CFR 801.109)
§ 874.4760 Nasopharyngoscope (flexible or rigid) and accessories.
(a)
Identification. A nasopharyngoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the nasopharyngoscope and is intended to examine or treat the nasal cavity and nasal pharynx. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel and flexible plastic. This generic type of device includes the antroscope, nasopharyngolaryngoscope, nasosinuscope, nasoscope, postrhinoscope, rhinoscope, salpingoscope, flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biospy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.