(87 days)
The HENKE- SASS, WOLF Sinuscope is intended to provide the physician with a means of endoscopic diagnostic and therapeutic sinus surgical procedures. The HENKE-SASS WOLF of America Inc. Sinuscope Accessories include Sheaths - to establish surgical access and the removal of debris and body fluids from the surgical site and to provide irrigation of the site with a sterile solution such as saline water. The Sinuscope and accessories are indicated for use in, but not limited to such procedures as examination of sinus passages and cavities, removal of abnormal growths such as polyps and facio-plastic surgery.
The HENKE-SASS, WOLF Sinuscopes are reusable hand-held instruments designed for a means of performing diagnostic and therapeutic sinus procedures. The HENKE-SASS, WOLF Sinuscopes and accessories have the same operating principals and intended uses as many of the competitive sinuscopes and accessories already in commercial distribution
The provided text does not contain information about acceptance criteria or a study proving device performance using quantitative metrics. The document is a 510(k) summary for a Nasopharyngoscope and Accessories (Sinuscope) from HENKE-SASS, WOLF of America, Inc. It primarily focuses on demonstrating substantial equivalence to predicate devices, material composition, and intended use, rather than detailed performance study results with acceptance criteria.
Therefore, most of the requested information cannot be extracted from this document.
Here's what can be inferred or explicitly stated from the provided text:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated as quantitative performance metrics. The implicit acceptance criterion is "substantial equivalence" to predicate devices, meaning the device performs as safely and effectively for its intended use.
- Reported Device Performance: Not presented with quantitative metrics. The document states:
- "The sinuscope itself is well recognized as being safe and effective for diagnostic and therapeutic sinus procedures."
- "The HENKE SASS WOLF Sinuscopes and accessories have the same operating principals and intended uses as many of the competitive sinuscopes and accessories already in commercial distribution."
- "The sinuscope material and design is identical to the predicate devices... In function, the sinuscopes and accessories are the same as the predicate devices."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- No specific test set or study data is mentioned that would allow reporting of sample size or data provenance. The submission relies on equivalence to existing devices.
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 applicable as no specific test set or ground truth establishment process is described beyond the general understanding that sinuscopes are "well recognized as being safe and effective."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable as no specific test set or adjudication process 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:
- No MRMC study was done, as this is a medical device (endoscope), not an AI-assisted diagnostic tool for "human readers."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable, as this is an endoscope, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- No explicit ground truth is mentioned in the context of a performance study. The "ground truth" for the device's safety and effectiveness appears to be established by the general clinical acceptance and regulatory history of similar predicate devices.
8. The sample size for the training set:
- Not applicable, as this is a physical medical device, not an AI model that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable, for the same reason as above.
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AUG / 3 1998
510(k) Summary / Statement Submitters Name:
HENKE- SASS, WOLF of America, Inc. Soroco Industrial Part, Rte. 131 529 Ashland Avenue Southbridge, MA 01550 Ph: 508-764-3200 Fax: 508-764-8242
Contact Name: Ellen Henke, Official Correspondent for Submission Wayne Knupp, Jr., Director Sales & Marketing-HENKE SASS WOLF Nasopharyngoscope and Accessories Name of Device:
SAFETY & EFFECTIVENESS DATA SUMMARY
Classification Name: Nasopharyngoscope and Accessories Common/Usual Name: Sinuscope and Accessories Proprietary Name: N/A
Classification: Class II Nasopharyngoscope and Accessories # 77 EOB Reg. # 874.4760
Performance Standards: Standards ISO 9001/EN 46001, applicable AAMI/ASTM standards, IEC 601-1 Standards.
Material Composition: Shaft; Surgical grade Stainless Steel (300 Series), certified according to ISO 58321 and ASTM 899, Body: Surgical grade Stainless Steel (300 Series - as above), Commercially pure titanium certified to ASTM B367, Anodized Aluminum Type 6061 with anodized coating per MIL-A-8635F, Sidearm; Surgical Grade Stainless Steel (300 Series - as above), Evepiece: DELRIN (Fed. Spec. L-P392A) or P.E.E.K. per MIL-P-46183, Type 1, Lenses; Glass (Type BK-7) or Optical Grade Pure Sapphire, Type Z. There are no significant differences to the materials, design or other noted features.
Intended Use: The HENKE- SASS, WOLF Sinuscope is intended to provide the physician with a means of endoscopic diagnostic and therapeutic sinus surgical procedures.
Device Description: The HENKE-SASS, WOLF Sinuscopes are reusable hand-held instruments designed for a means of performing diagnostic and therapeutic sinus procedures. The HENKE-SASS, WOLF Sinuscopes and accessories have the same operating principals and intended uses as many of the competitive sinuscopes and accessories already in commercial distribution
Predicate Devices: Smith& Nephew Richards Sinuscope K932988, Richards Medical Company Endoscopes for Sinus Surgery K874215(manufactured by HENKE SASS WOLF, GmbH)
Comparison of Technological Characteristics: The sinuscope material and design is identical to the predicate devices (Manufactured by HENKE SASS WOLF on an OEM basis). In function, the sinuscopes and accessories are the same as the predicate devices.
Safety and Efficacy Information: The sinuscope itself is well recognized as being safe and effective for diagnostic and therapeutic sinus procedures. The HENKE SASS WOLF Sinuscopes and accessories have the same operating principals and intended uses as many of the competitive sinuscopes and accessories already in commercial distribution.
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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 3 1998
Ellen J. Henke Official Correspondent Henke Sass Wolf of America, Inc. Soroco Industrial Park, Rte. 131 529 Ashland Avenue Southbridge, MA 01550
Re:
K981751 Sinuscope and Accessories Dated: May 13, 1998 Received: May 18, 1998 Regulatory class: II 21 CFR 874.4760/Procode: 77 EOB
Dear Ms. Henke:
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, Drug, and Cosmetic Act (Act). 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, 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 (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further 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.
If you desire specific advice for your device on our 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/dsmaldsmamain.html".
Sincerely yours,
William Yu, Ph.D.
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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510(k) Number (if known):
Device Name: Nasopharyngoscope and Accessories (Sinuscope)
Indications For Use:
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from the surgical site and to provide irrigation of the site with a sterile solution such as saline water.
The Sinuscope and accessories are indicated for use in, but not limited to such procedures as examination of sinus passages and cavities, removal of abnormal growths such as polyps and facio-plastic surgery.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Thrid C. Sejerm
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT and Radiological Devices 510(k) Number
'rescription Use
P--21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 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.