(140 days)
A device intended to be used as a disposable barrier for a surgical lighting system and which allows a surgical team member to manually adjust the lighting system. This is a single-use device
The Surgical Light Handle Cover is a polycarbonate injection molded device shaped to fit a surgical light that has release buttons protruding from the surgical light handle. The Surgical Light Handle Cover has apertures located at the end of the device, proximal to the surgical light, which correspond to the release buttons on the surgical light handle. When the Surgical Light Handle Cover is attached to the light, the release buttons will interface with the apertures to secure the Surgical Light Handle Cover to the light handle.
The Surgical Light Handle Cover is hollow in the center, with transparent polycarbonate located near the distal end. The transparent end permits the use of a recording device, which may be mounted onto the surgical light. The transparent end allows light to pass through for the purpose of recording images, it does not provide image enhancement or magnification.
The provided text describes the acceptance criteria and the study results for the "Surgical Light Handle Cover" device (K133554).
The study did not involve AI assistance, human readers, or the establishment of ground truth by experts in the context of diagnostic accuracy. This device is a physical medical accessory, and its performance evaluation focuses on manufacturing, sterility, biocompatibility, and physical functionality rather than diagnostic capabilities.
Here's a breakdown of the requested information based on the provided text, with clarifications where the questions are not directly applicable to this type of device:
1. Table of Acceptance Criteria and Reported Device Performance
| Requirement | Specification | Result |
|---|---|---|
| Packaging | ||
| Simulated Distribution Test | ASTM D4169 | Pass |
| Dye Migration Test | ASTM F1929 | Pass |
| Seal Peel Test | ASTM F88 | Pass |
| Inspection for Shipping Damage | Visual Inspection | Pass |
| Sterility | ||
| SAL (Sterility Assurance Level) 10^-6 | ISO 11135-1 | Pass |
| EO/ECH Residuals | ISO 10993-7 | Pass |
| Material Compatibility Evaluation | ||
| Cytotoxicity | ISO Elution | Pass |
| Material Leachables | USP Physical-Chemical Analysis | Pass |
| Functional Requirements | ||
| Product must be easily installed and removed | Attached/Detached Surgical Light Handle Cover to surgical light | Pass |
| Product must not interfere with the functionality of surgical light | With Surgical Light Handle Cover attached: rotate light, move light in transverse direction, compare visual clarity | Pass |
2. Sample size used for the test set and the data provenance
The document does not specify exact sample sizes for each test listed in the "Performance Data Summary." For tests like "Simulated Distribution Test" (ASTM D4169), "Dye Migration Test" (ASTM F1929), "Seal Peel Test" (ASTM F88), "Sterility" (ISO 11135-1), "EO/ECH Residuals" (ISO 10993-7), "Cytotoxicity" (ISO Elution), and "Material Leachables" (USP Physical-Chemical Analysis), the sample sizes would typically be determined by the specific ASTM/ISO standards referenced, but they are not detailed in this summary.
For the functional requirements ("Product must be easily installed and removed" and "Product must not interfere with the functionality of surgical light"), the test method indicates empirical assessment on a surgical light, but no specific number of trials or devices tested is provided.
The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective/prospective, but given that it's a 510(k) submission for a medical device manufacturer, the testing would have been conducted by or for Microtek Medical Inc., an Ecolab Company, likely in a controlled laboratory setting.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable to the evaluation of this device. The "ground truth" for this type of medical accessory is not established by clinical expert interpretation or diagnostic accuracy. Instead, it's based on objective engineering specifications, regulatory standards (ASTM, ISO), and functional performance against predefined criteria. For example:
- Sterility: Achieved if the Sterility Assurance Level (SAL) meets 10^-6 as per ISO 11135-1.
- Packaging: Pass/fail based on meeting the requirements of ASTM standards.
- Functionality: Pass/fail based on whether the device can be attached/detached and doesn't impede light movement or clarity.
No clinical experts or radiologists were involved in establishing "ground truth" for these performance metrics.
4. Adjudication method for the test set
This question is not applicable. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies involving interpretation of medical images or patient data where there might be inter-reader variability. For this device, the tests are objective: either a package seal passes ASTM F88 or it doesn't; either an item is sterile to the specified SAL or it isn't. Discrepancies would be resolved by re-testing or reviewing the test methodology rather than expert consensus on an interpretation.
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, an MRMC comparative effectiveness study was not done. This device is a physical surgical light handle cover, not an AI-powered diagnostic or assistive tool. Therefore, there is no AI component, no human reader performance to improve, and no effect size to report in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone (algorithm only) performance evaluation was not done. This device is a physical product and does not involve any algorithms or AI for standalone performance assessment.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
As discussed in point 3, the concept of "ground truth" as typically applied to diagnostic AI is not relevant here. The "ground truth" for this device's performance is defined by:
- Adherence to established international standards (e.g., ASTM, ISO) for material properties, sterility, and packaging integrity.
- Meeting predefined functional specifications (e.g., ease of installation, non-interference with light function).
- Compliance with biocompatibility requirements for medical devices.
8. The sample size for the training set
This question is not applicable. This device is not an AI algorithm, and therefore there is no "training set" in the machine learning sense. The device is manufactured based on a design and then tested against the criteria outlined above.
9. How the ground truth for the training set was established
This question is not applicable. As there is no training set for an AI algorithm, there is no "ground truth" to establish for such a set.
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Image /page/0/Picture/1 description: The image shows the logo for Ecolab Inc. The text "Ecolab Inc." is at the top of the image. Below that is the Ecolab logo, with the word "ECOLAB" in bold black letters and a symbol in the middle of the O. There is a registered trademark symbol to the right of the B.
:
APR 0 8 2014 K133554
Section 5: 510(k) Summary
Surgical Light Handle Cover
As required by 21 CFR 807.92.
| Date: | November 11, 2013 | |
|---|---|---|
| Administrative Information | ||
| Submitter: | Microtek Medical Inc., an Ecolab Company | |
| EstablishmentRegistration Number: | 1043582. | |
| Contact Person: | Andy Roller370 Wabasha Street NorthSt. Paul, MN 55102-1390Sr. Regulatory Specialist651.293.2080 | |
| Device Identification | ||
| Device Name: | Surgical Light Handle Cover | |
| Common Name: | Surgical Light Accessory | |
| Device Classification Name: | Light, Surgical, Accessories | |
| Device Classification: | Class II | |
| Panel: | General and Plastic Surgery | |
| Classification Regulation: | 878.4580 | |
| Product Code: | FTA |
Performance Standards: No Recognized Consensus Standards
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Ecolab Inc.
Surgical Light Handle Cover
| Predicate Device: | Surgical Lamp Handle and Cover, cleared on 3/20/1999 via K901154 |
|---|---|
| Trade Name: | Skytron Disposable Light Handle Cover |
Device Description
The Surgical Light Handle Cover is a polycarbonate injection molded device shaped to fit a surgical light that has release buttons protruding from the surgical light handle. The Surgical Light Handle Cover has apertures located at the end of the device, proximal to the surgical light, which correspond to the release buttons on the surgical light handle. When the Surgical Light Handle Cover is attached to the light, the release buttons will interface with the apertures to secure the Surgical Light Handle Cover to the light handle.
The Surgical Light Handle Cover is hollow in the center, with transparent polycarbonate located near the distal end. The transparent end permits the use of a recording device, which may be mounted onto the surgical light. The transparent end allows light to pass through for the purpose of recording images, it does not provide image enhancement or magnification.
Statement of Intended Use
The Surgical Light Handle Cover is intended to be used as a disposable barrier for a surgical lighting system and which allows the surgical team member to manually adjust the lighting system. This is a single-use device.
Substantial Equivalence Discussion
The predicate device and design basis for the Surgical Light Handle Cover is the Microtek Medical Surgical Lamp Handle and Cover (K901154, cleared 3/20/1990). The fundamental scientific technology of the device remains unchanged in that it is a disposable sterile light cover that allows the user to adjust position of the light during surgical procedures. The following table illustrates the similarities and differences in the product designs.
| Property orCharacteristic | Proposed Device -Surgical Light Handle Cover | Predicate Device -Surgical Lamp Handle andCover (K901154) |
|---|---|---|
| IntendedUse/Indications forUse | A device intended to be used as adisposable barrier for a surgicallighting system and which allows asurgical team member to manually | A device intended to be used asa disposable barrier for asurgical lighting system andwhich allows a surgical team |
| Table 1: Substantial Equivalence | ||||
|---|---|---|---|---|
| -- | -- | ---------------------------------- | -- | -- |
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| adjust the lighting system. This is asingle-use device | member to manually adjust thelighting system. This is asingle-use device | |
|---|---|---|
| Conditions of Use | Single Use, Disposable | Single Use, Disposable |
| Materials | Polycarbonate Handle Cover | Polypropylene Handle Cover |
| Property orCharacteristic | Proposed Device -Surgical Light Handle Cover | Predicate Device -Surgical Lamp Handle andCover (K901154) |
| Color | Clear - Frosted | |
| Sterility | Provided sterile | Provided sterile |
| Sterility AssuranceLevel | 10-6 via EO Gas | 10-3 via Gamma Radiation |
| Principle ofOperation | Sterile cover to allow manipulationof a surgical light | Sterile cover to allowmanipulation of a surgical light |
| Interface withSurgical Light | Fully detachable | Lamp Handle - Not detachableHandle Cover - Fullydetachable |
| Transparent DistalEnd | Yes |
Performance Data Summary
Table 2: Performance Data Summary of the Surgical Light Handle Cover
| Requirement | Specification | Method | Result | |
|---|---|---|---|---|
| Packaging | Simulated Distribution-Test | ASTM D4169 | Pass | |
| Dye Migration Test | ASTM F1929 | Pass | ||
| Seal Peel Test | ASTM F88 | Pass | ||
| Inspection for ShippingDamage | Visual Inspection | Pass | ||
| Sterility | SAL 10-6 | ISO 11135-1 | Pass | |
| EO/ECH Residuals | ISO 10993-7 | Pass | ||
| MaterialCompatibilityEvaluation | Cytotoxicity | ISO Elution | Pass | |
| Material Leachables | USP Physical-ChemicalAnalysis | Pass | ||
| FunctionalRequirements | Product must be easilyinstalled and removed | Attached/Detached SurgicalLight Handle Cover to surgicallight | Pass | |
| Product must not interferewith the functionality ofsurgical light | With Surgical Light HandleCover attached: rotate light,move light in transversedirection, compare visual clarity | Pass |
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Substantial Equivalence Conclusion
The differences between the Surgical Light Handle Cover and the predicate device do not constitute a new intended use, and the differences in technological characteristics do not raise different questions of safety and effectiveness. Furthermore, the changes to the device design do not impact the fundamental scientific technology or principle of operation, which is to allow a user to manipulate a surgical light during surgical procedures using a disposable sterile cover.
The Surgical Light Handle Cover is substantially equivalent to the predicate device cleared under K901154.
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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 8, 2014
Microtek Medical, Incorporated An Ecolab Company Mr. Andy Roller Senior Regulatory Specialist 370 Wabasha Street North St. Paul. MN 55102
Re: K133554
Trade/Device Name: Surgical Light Handle Cover Regulation Number: 21 CFR 878.4580 Regulation Name: Light, Surgical, Accessories Regulatory Class: II Product Code: FTA Dated: January 30, 2014 Received: February 12, 2014
Dear Mr. Roller:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into cither class II (Special Controls) or class III (PMA), it may be subject to 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.
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Page 2 - Mr. Roller
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fdagov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Tejashri
Clinical D
DAGRID
Teiashri Purohit-Sheth, M.D. Clinical Deputy Director
FOR
Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Statement of Indications for Use Section 4:
510(k) Number (if known): _ K133554
Device Name: Surgical Light Handle Cover
Model Number: B1-715-65
Indications For Use: A device intended to be used as a disposable barrier for a surgical lighting system and which allows a surgical team member to manually adjust the lighting system. This is a single-use device
Image /page/6/Picture/7 description: The image shows the phrase "Prescription Use (Part 21 CFR 801 Subpart D)" in bold font. There is a line underneath the phrase. Above the phrase is a large X mark.
AND/OR
Over-The-Counter Use (2) CFR 801 Subparl C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (CDDE) Elizabeth F. Claverie -S 2014.04.07 22:55:00 -04'00'
4-1
§ 878.4580 Surgical lamp.
(a)
Identification. A surgical lamp (including a fixture) is a device intended to be used to provide visible illumination of the surgical field or the patient.(b)
Classification. Class II (special controls). The device, when it is an operating room lamp, a surgical instrument light, a surgical floor standing light, an endoscopic surgical light, a surgical light connector, a ceiling mounted surgical light, a surgical light carrier, surgical light accessories, a surgical lamp, a remote illuminator, or an incandescent surgical lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.