(25 days)
The Karl Storz Trans-Nasal Esophagoscopes are designed to be used by qualified surgeons and physicians and are indicated for endoscopic access and examination of the nasal sinuses, larynx, esophagus and gastro-esophageal junction and, using additional accessories, to perform various diagnostic and therapeutic procedures.
The Karl Storz Trans-Nasal Esophagoscopes are manually operated surgical devices, flexible fiberoptic telescopes that utilize fiber-optic technology. The body contact portions of the Kall Storz Trans-Nasal Esophagoscopes are manufactured using medical grade polyurethane.
This 510(k) summary (K051972) is for the Karl Storz Trans-Nasal Esophagoscopes. This document is a Summary of Safety and Effectiveness, which typically summarizes information from a 510(k) submission, including a declaration of substantial equivalence to a predicate device. It does not describe a clinical study or performance data against specific acceptance criteria in the way one would for a novel AI/ML device or a device requiring significant clinical validation.
Here's an analysis based on the provided text, and why most of your requested points cannot be answered from this document:
1. A table of acceptance criteria and the reported device performance
This document does not contain a table of acceptance criteria or performance data for the Karl Storz Trans-Nasal Esophagoscopes. The 510(k) relies on establishing substantial equivalence to existing predicate devices rather than proving performance against novel acceptance criteria.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. No test set or associated data is described, as the submission focuses on substantial equivalence.
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. No ground truth establishment or expert involvement for a test set is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set or adjudication is mentioned.
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 a manually operated flexible fiberoptic endoscope, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithm-only device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The concept of "ground truth" as it relates to clinical performance studies is not relevant to this 510(k) submission. The device's "truth" or acceptability is based on its similarity to legally marketed predicate devices.
8. The sample size for the training set
Not applicable. This device does not involve machine learning or a training set.
9. How the ground truth for the training set was established
Not applicable. This device does not involve machine learning or ground truth for a training set.
Summary of what the document does provide regarding "acceptance criteria" and "study":
The "acceptance criteria" in a 510(k) of this nature are inherently tied to demonstrating substantial equivalence to a predicate device, rather than meeting specific quantifiable performance metrics.
Substantial Equivalence "Study" (Rationale):
The "study" or justification for the device's acceptance is the comparison to predicate devices.
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Predicate Devices:
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Reasoning for Substantial Equivalence: The document states:
"The Karl Storz Trans-Nasal Esophagoscopes are substantially equivalent to the predicate devices since than haudi ESOphagoscopes are substantialiy are the same. The minor differences between the Karl Storz and interined does Esophagoscopes and the KSEA Rhino-Laryngo-Broncho-Fiberscope and Broncho-Fiberscope and Broncho-Fiberscope (K981458), and the TNE-2000 marketed by Vision Sciences, Inc. (K031786) raise no new issues of safety and effectiveness, as these design differences have no affect on the performance, function or intended use of the devices."
This statement implies that the device's design, materials (medical grade polyurethane for body contact portions), performance, function, and intended use are sufficiently similar to the predicate devices, and any minor differences do not raise new safety or effectiveness concerns. This is the "proof" or "study" in the context of this traditional 510(k).
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AUG 15 2005
Karl Storz Endoscopy-America, Inc.
600 Corporate Pointe 5th Floor Culver City, California 90230-7600 Phone 310 338 8100
Toll Free 800 421 0837 Fax 310 410 5527
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR 807.92. All data included in this document is accurate and complete to the best of KSEA's knowledge.
| Applicant: | Karl Storz Endoscopy - America, Inc.600 Corporate Pointe DriveCulver City, CA 90230(310) 410-2769 |
|---|---|
| Contact: | Yvonne FernandezSenior Regulatory Affairs Specialist |
| Device Identification: | Common Name - Flexible Esophagoscopes |
Trade Name - Karl Storz Trans-Nasal Esophagoscopes (11301BN1, 11302BD1)
Indication: The Karl Storz Trans-Nasal Esophagoscopes are designed to be used by qualified surgeons and physicians and are indicated for endoscopic access and examination of the nasal sinuses, larynx, esophagus and gastro-esophageal junction and, using additional accessories, to perform various diagnostic and therapeutic procedures.
Device Description: The Karl Storz Trans-Nasal Esophagoscopes are manually operated surgical devices, flexible fiberoptic telescopes that utilize fiber-optic technology. The body contact portions of the Kall Storz Trans-Nasal Esophagoscopes are manufactured using medical grade polyurethane.
Substantial Equivalence: The Karl Storz Trans-Nasal Esophagoscopes are substantially equivalent to the predicate devices since than haudi ESOphagoscopes are substantialiy are the same. The minor differences between the Karl Storz and interined does Esophagoscopes and the KSEA Rhino-Laryngo-Broncho-Fiberscope and Broncho-Fiberscope and Broncho-Fiberscope (K981458), and the TNE-2000 marketed by Vision Sciences, Inc. (K031786) raise no new issues of safety and effectiveness, as these design differences have no affect on the performance, function or intended use of the devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/1/Picture/2 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is a stylized symbol that resembles a person with their arms outstretched.
AUG 1 5 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Karl Storz Endoscopy-America, Inc. c/o Yvonne Fernandez Senior Regulatory Affairs Specialist 600 Corporate Pointe, 5th Floor Culver City, CA 90230-7600
Re: K051972
Trade/Device Name: Trans-Nasal Esophagoscope Regulation Number: 21 CFR 874.4710 Regulation Name: Esophagoscopes and accessories Regulatory Class: Class II Product Code: EOX Dated: July 20, 2005 Received: July 21, 2005
Dear Ms. Fernandez:
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.
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Page 2 - Yvonne Fernandez
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) 827-8910. 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/industry/support/index.html.
Sincerely yours,
David M. Whipple
Acting Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): Not yet assigned
Device Name: Karl Storz Trans-Nasal Esophagoscopes
Indications for Use:
The Karl Storz Trans-Nasal Esophagoscopes are designed to be used by qualified surgeons and physicians and are indicated for endoscopic access and examination of the nasal sinuses, larynx, esophagus and gastro-esophageal junction and, using additional accessories, to perform various diagnostic and therapeutic procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use: (Per 21 CFR 801.109) ______________________________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
Kassitkova
Division of Ophthalmic Ear. Nose and Throat Devises
510(k) Number K051972
§ 874.4710 Esophagoscope (flexible or rigid) and accessories.
(a)
Identification. An esophagoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the esophagoscope and is intended to examine or treat esophageal malfunction symptoms, esophageal or mediastinal disease, or to remove foreign bodies from the esophagus. When inserted, the device extends from the area of the hypopharynx to the stomach. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.