(43 days)
The KSEA Miniature Endoscope is indicated for use in visualization of sinus anatomy and pathology.
The KSEA Miniature Endoscope is a manually operated, reusable surgical device that is provided to the end-user in a non-sterile condition. The device is a flexible fiber optic telescope which utilizes fiber-optic technology to perform the intended use.
This K070752 510(k) submission for the Karl Storz Miniature Endoscope (KSEA Miniature Endoscope) does not contain a study that demonstrates the device meets specific acceptance criteria in terms of performance metrics like sensitivity, specificity, or accuracy. Instead, this submission focuses on demonstrating substantial equivalence to predicate devices. This means the manufacturer is asserting that their new device is as safe and effective as devices already legally marketed, without needing to prove new performance claims through extensive clinical trials.
Therefore, the requested information elements (1, 2, 3, 4, 5, 6, 7, 8, 9) regarding acceptance criteria and performance studies are not applicable in the context of this 510(k) submission, as it relies on substantial equivalence rather than novel performance claims.
Here's a breakdown based on the provided document:
1. Table of acceptance criteria and reported device performance:
- Not Applicable. The submission does not provide acceptance criteria in terms of performance metrics (e.g., accuracy, sensitivity, specificity) for the device's clinical function. Its acceptance by the FDA is based on demonstrating substantial equivalence to predicate devices, meaning it has similar technological characteristics and intended use, and does not raise new questions of safety or effectiveness.
2. Sample size used for the test set and the data provenance:
- Not Applicable. There is no "test set" in the context of a performance study for this 510(k) submission. Substantial equivalence relies on comparing the device's design and intended use to existing predicate devices, not on new clinical performance data from a sample set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. As there is no test set for a performance study, there are no experts establishing ground truth in this context.
4. Adjudication method for the test set:
- Not Applicable. No test set was used to assess performance.
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 flexible fiber optic endoscope, not an AI-powered diagnostic tool. Therefore, an MRMC study and AI assistance are not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a medical device, not an algorithm.
7. The type of ground truth used:
- Not Applicable. No clinical performance study requiring ground truth was conducted for this 510(k) submission.
8. The sample size for the training set:
- Not Applicable. This is a hardware medical device, not a machine learning algorithm requiring a training set.
9. How the ground truth for the training set was established:
- Not Applicable. This is a hardware medical device, not a machine learning algorithm.
Summary of the 510(k) Filing for K070752 (Karl Storz Miniature Endoscope):
The K070752 510(k) submission is for the Karl Storz Miniature Endoscope. The core of the submission is to demonstrate substantial equivalence to already legally marketed predicate devices.
The key information provided relates to this substantial equivalence:
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Predicate Devices:
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Intended Use: The KSEA Miniature Endoscope is indicated for use in visualization of sinus anatomy and pathology. This intended use is comparable to the visualization purposes of the predicate devices in different anatomical areas (coronary vessels, nasal cavity/larynx/pharynx, salivary gland).
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Technological Characteristics Comparison (as per Substantial Equivalence Chart):
- Shaft Diameter: 0.5 mm (matches Olympus Angioscope)
- Working Length: 100 cm (falls within the range of predicates: 30 cm - 130 cm)
- Viewing Angle: 0° (matches all predicates)
- Field of View: 70° (similar to predicates: 75° for Olympus devices, 70° for KSEA Sialoendoscope)
- Optics: Fiber optic (matches all predicates)
Conclusion from the 510(k) Summary:
The submission states that "The KSEA Miniature Endoscope is substantially equivalent to the predicate devices since the basic features, design, and intended uses are similar. The minor differences between the KSEA Miniature Endoscope and the predicate devices 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."
The FDA's letter (Page 2) confirms this, stating, "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."
Therefore, the "proof" that this device meets acceptance criteria is the successful demonstration of substantial equivalence to predicate devices, as accepted by the FDA. No specific performance study with numerical criteria was required or provided in this particular 510(k) submission.
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Image /page/0/Picture/1 description: The image shows the logo for Karl Storz Endoscopy. The logo is black and white and features the word "STORZ" in large, bold letters. Below the word "STORZ" is the text "KARL STORZ ENDOSCOPY" in a smaller font.
510(k) SUMMARY
1
| Sponsor/Submitter: | Karl Storz Endoscopy - America, Inc.600 Corporate PointeCulver City, CA 90230-7600Phone: (310) 338-8100Fax: (310) 410-5519 | MAY - 1 2007 |
|---|---|---|
| Contact Person: | Crystal DizolRegulatory Affairs AssociateEmail: cdizol@ksea.com | |
| Date of Submission: | April 26, 2007 | |
| Device Trade Name: | Karl Storz Miniature Endoscope | |
| Common Name: | Flexible fiberscope | |
| Classification Name: | Nasopharyngoscope (flexible or rigid) and accessories | |
| Regulation Number: | 21 CFR 874.4760 | |
| Product Code: | EOB | |
| Predicate Device(s): | Olympus Angioscope (K911278)Olympus ENF Type XP Rhino-Laryngo Fiberscope (K013591, K011869)KSEA Sialoendoscope (K012527) | |
| Device Description: | The KSEA Miniature Endoscope is a manually operated, reusable surgical devicethat is provided to the end-user in a non-sterile condition. The device is a flexiblefiber optic telescope which utilizes fiber-optic technology to perform the intendeduse. | |
| Indications for Use: | The KSEA Miniature Endoscope is indicated for use in visualization of sinusanatomy and pathology. | |
| TechnologicalCharacteristics: | The KSEA Miniature Endoscope and its predicate devices are flexible fiber optictelescopes that use fiber optic technology to transmit an image from the distal tothe proximal end of the device. | |
| Summary ofSubstantialEquivalence: | The KSEA Miniature Endoscope is substantially equivalent to the predicatedevices since the basic features, design, and intended uses are similar. Theminor differences between the KSEA Miniature Endoscope and the predicatedevices raise no new issues of safety and effectiveness, as these designdifferences have no affect on the performance, function, or intended use of thedevices. For a comparison between the KSEA Miniature Endoscope and thepredicate devices, refer to the attached substantial equivalence chart. |
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Att: Substantial Equivalence Chart for Karl Storz Miniature Endoscope
:
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KARL STORZ ENDOSCOP
SUBSTANTIAL EQUIVALENCE CHART FOR KARL STORZ
MINIATURE ENDOSCOPE, 11565
| Manufacturer | ShaftDiameter | WorkingLength | ViewingAngle | Field of View | Optics | Intended Use |
|---|---|---|---|---|---|---|
| KSEA: 11565Miniature Endoscope | 0.5 mm | 100 cm | 0° | 70° | Fiber optic | Used for visualization of sinus anatomy and pathology. |
| Olympus: Angioscope(K911278) | 0.5 mm | 130 cm | 0° | 75° | Fiber optic | Used for viewing the peripheral and/or coronary vessels. |
| Olympus: ENF Type XPRhino-LaryngoFiberscope (K013591,K011869) | 1.8 mm | 30 cm | 0° | 75° | Fiber optic | Used for observing the nasal cavity, larynx and pharynx. |
| KSEA: 11576Sialoendoscope(K012527) | 0.75 mm | 30 cm | 0° | 70° | Fiber optic | Used for visualization of the surgical site in salivary glanddiagnostic and therapeutic procedures. |
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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 stylized human figure with outstretched arms, representing care and protection. The figure is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 1 2007
Karl Storz Endoscopy-America, Inc. c/o Crystal K. Dizol 600 Corporate Pointe Culver City, Ca 90230-7600
Re: K070752
Trade/Device Name: KSEA Miniature Endoscope Regulation Number: 21 CFR 874.4760 Regulation Name: Nasopharyngoscope Regulatory Class: Class II Product Code: EOB Dated: March 15, 2007 Received: March 19, 2007
Dear Ms. Dizol:
We have reviewed your Section 510(k) premarket notification of intent to market the device wf nave a showe 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 I ou may, ateres, mains 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 11 your de roo is onach 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 I tease oc acrised alla I Drivision that your device complies with other requirements of the Act that I Dr Has Intacted and regulations administered by other Federal agencies. You must or any I oderal 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 Orth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality by evense (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Crystal K. Dizol
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 (240) 276-0115. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
M.B. Eichelman SMD
Malvina B. Eydelman, M.D. 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):
Device Name: KSEA Miniature Endoscope
Indications for Use: The Miniature Endoscope is indicated for use in visualization of sinus anatomy and pathology.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Amalot
(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devices
510(k) Number: K070752
Prescription Use: [$\checkmark$] OR Over-The-Counter Use: __
(Per 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
§ 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.