(258 days)
Not Found
No
The document describes a motorized surgical device for cutting and debriding tissue and bone. There is no mention of AI, ML, image processing, or any data-driven decision-making capabilities. The performance studies focus on electrical safety, EMC, sterilization, and mechanical performance (rotation speed and torque).
No
The device is described as a motorized surgical system used for cutting, drilling, debriding, sawing, and shaving tissue or bone, indicating it performs surgical procedures rather than offering therapy.
No
Explanation: The device is described as a "motorized surgical device system" intended for "controlled cutting, drilling, debriding, sawing, and shaving for the ablation, excision, removal, or transection of tissue or bone" during surgical procedures. Its function is to perform surgical interventions, not to diagnose conditions.
No
The device description explicitly states it is a "motorized surgical device system" with "system components include a control unit used in conjunction with the High-Speed Micro Motor that houses the high-speed handpieces and DrillCut-X® II Shaver handpieces." This indicates significant hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the system is for "controlled cutting, drilling, debriding, sawing, and shaving for the ablation, excision, removal, or transection of tissue or bone during head, neck, ENT, or otoneurological surgical procedures." This describes a surgical tool used directly on the patient's body.
- Device Description: The description reinforces this by calling it a "motorized surgical device system used for the excision, ablation, removal or transection of bones/tissues during head, neck, ENT, or otoneurological surgical procedures."
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.) outside of the body to diagnose a condition, monitor treatment, or screen for diseases. IVDs are typically used in laboratories or point-of-care settings for diagnostic purposes.
This device is a surgical instrument used for physical manipulation of tissue and bone during surgery, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The UNIDRIVE® S III ENT system consists of an active control unit used in conjunction with the High-Speed Micro Motor and DrillCut-X® II Shaver handpieces. The system is intended for use by qualified surgeons to provide controlled cutting, drilling, debriding, sawing, and shaving for the ablation, excision, removal, or transection of tissue or bone during head, neck, ENT, or otoneurological surgical procedures.
Product codes (comma separated list FDA assigned to the subject device)
ERL
Device Description
The UNIDRIVE S III ENT is a motorized surgical device system used for the excision, ablation, removal or transection of bones/tissues during head, neck, ENT, or otoneurological surgical procedures. The system components include a control unit used in conjunction with the High-Speed Micro Motor that houses the high-speed handpieces and DrillCut-X® II Shaver handpieces.
The modifications made to the UNIDRIVE® S III ENT system is the addition of the DrillCut-X® II-35 and DrillCut-X® II-35 N Shaver handpieces. Additional accessories used with the UNIDRIVE S III ENT system include the shaver blades, sinus burrs and the sinus burr 35k.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
head, neck, ENT, or otoneurological
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified surgeons
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Data: The device has been tested and passed the electrical safety testing and EMC testing, which is certified to be Class I protection against electrical shock. The UNIDRIVE S III ENT system follows the FDA recognized consensus standards and is tested according to the following standards: IEC 60601-1, IEC 60601-1-2, ISO 14971, ISO 10993. Cleaning and sterilization validations were conducted for patient-contacting components. The reprocessing data submitted complies with the following standards: ANSI/AAMI ST81:2004/(R) 2010 ANSI/AAMI ST79: 2010/A4:2013 AAMI TIR 12:2010 ANSI/AAMI/ISO 17665-1:2006 ANSI/AAMI/ISO 17665-2:2009 AAMI TIR 39:2009. The following bench testing was performed to ensure that the UNIDRIVE S III ENT system meets its design specification: Inspection of rotation speed and torque. Bench testing demonstrated substantial equivalence to the predicate device.
Clinical Performance Data: Clinical testing was not required to demonstrate the substantial equivalence to the predicate device. Non-clinical bench testing was sufficient to assess safety and effectiveness and to establish the substantial equivalence of the modifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 874.4250 Ear, nose, and throat electric or pneumatic surgical drill.
(a)
Identification. An ear, nose, and throat electric or pneumatic surgical drill is a rotating drilling device, including the handpiece, that is intended to drive various accessories, such as an ear, nose, and throat bur (§ 874.4140), for the controlled incision or removal of bone in the ear, nose, and throat area.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized symbol. To the right is the FDA logo, with the letters "FDA" in a blue square and the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
October 22, 2020
Karl Storz Endoscopy-America, Inc. Alita McElroy Regulatory Affairs Specialist 2151 E. Grand Avenue El Segundo, California 90245
Re: K200318
Trade/Device Name: UNIDRIVE S II ENT, DrillCut-X II-35 Shaver Handpiece, DrillCut-X II-35 N Shaver Handpiece Regulation Number: 21 CFR 874.4250 Regulation Name: Ear, nose, and throat electric or pneumatic surgical drill Regulatory Class: Class II Product Code: ERL Dated: July 21, 2020 Received: July 23, 2020
Dear Alita McElroy:
We have reviewed vour 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmr/pmn.cfm identifies combination product submissions. 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 either 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.
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
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Joyce C. Lin-S
for Malvina Eydelman, M.D. Director OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K200318
Device Name UNIDRIVE S III ENT
Indications for Use (Describe)
The UNIDRIVE® S III ENT system consists of an active control unit used in conjunction with the High-Speed Micro Motor and DrillCut-X® II Shaver handpieces. The system is intended for use by qualified surgeons to provide controlled cutting, drilling, debriding, sawing, and shaving for the ablation, excision, removal, or transection of tissue or bone during head, neck, ENT, or otoneurological surgical procedures.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image shows the logo for Karl Storz Endoskope. The word "STORZ" is written in large, bold, blue letters. Below that, the words "KARL STORZ - ENDOSKOPE" are written in smaller, blue letters.
K200318 510(k) Summary
This 510(k) Summary 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.
| Submitter: | KARL STORZ Endoscopy-America, Inc.
2151 E. Grand Avenue
EI Segundo, CA 90245 |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Alita McElroy
Regulatory Affairs Specialist
Phone: (424) 218-8376
Fax: (424) 218-8519 |
| Date of Preparation: | October 22, 2020 |
| Type of 510(k)
Submission: | Traditional |
| Device
Identification: | Trade Name: UNIDRIVE S III ENT
Classification Name: Drill, Surgical, ENT (Electric Or
Pneumatic) Including Handpiece |
| Regulatory Class: | II |
| Product Code: | ERL |
| Regulation: | 21 CFR 874.4250 (Ear, nose and throat electric or pneumatic
surgical drill) |
| Predicate Device(s): | Predicate Device: UNIDRIVE S III ENT (K150969)
The predicate device has not been subject to a design-related
recall. |
| Device Description: | The UNIDRIVE S III ENT is a motorized surgical device
system used for the excision, ablation, removal or transection
of bones/tissues during head, neck, ENT, or otoneurological
surgical procedures. The system components include a control
unit used in conjunction with the High-Speed Micro Motor that
houses the high-speed handpieces and DrillCut-X® II Shaver
handpieces.
The modifications made to the UNIDRIVE® S III ENT system
is the addition of the DrillCut-X® II-35 and DrillCut-X® II-35
N Shaver handpieces. Additional accessories used with the
UNIDRIVE S III ENT system include the shaver blades, sinus
burrs and the sinus burr 35k. |
| Intended Use: | The UNIDRIVE S III ENT system consists of an active control
unit used in conjunction with the High-Speed Micro Motor and
DrillCut-X® II Shaver handpieces. The system is intended for
use by qualified surgeons to provide controlled cutting,
drilling, debriding, sawing, and shaving for the ablation,
excision, removal, or transection of tissue or bone during head,
neck, ENT, or otoneurological surgical procedures. |
| Indications For Use: | The UNIDRIVE S III ENT system consists of an active control
unit used in conjunction with the High-Speed Micro Motor and
DrillCut-X® II Shaver handpieces. The system is intended for
use by qualified surgeons to provide controlled cutting,
drilling, debriding, sawing, and shaving for the ablation,
excision, removal, or transection of tissue or bone during head,
neck, ENT, or otoneurological surgical procedures. |
| Technological
Characteristics: | The UNIDRIVE S III ENT is a modification of and
substantially equivalent to the UNIDRIVE S III ENT
(K150969) in terms of its indication for use, principle of
operation, patient-contacting materials and reprocessing
methods.
The subject device includes the addition of the DrillCut-X® II-
35 and DrillCut-X® II-35 N Shaver handpieces that have a
maximum rotational speed of 35,000 RPM in comparison with
the shaver handpieces of the predicate device that have a
maximum rotational speed of 12,000 RPM. |
| Non-Clinical
Performance Data: | The device has been tested and passed the electrical safety
testing and EMC testing, which is certified to be Class I
protection against electrical shock.
The UNIDRIVE S III ENT system follows the FDA
recognized consensus standards and is tested according to the
following standards:
• IEC 60601-1
• IEC 60601-1-2
• ISO 14971
• ISO 10993 |
| | |
| | Cleaning and sterilization validations were conducted for
patient-contacting components. The reprocessing data
submitted complies with the following standards:
ANSI/AAMI ST81:2004/(R) 2010 ANSI/AAMI ST79: 2010/A4:2013 AAMI TIR 12:2010 ANSI/AAMI/ISO 17665-1:2006 ANSI/AAMI/ISO 17665-2:2009 AAMI TIR 39:2009 The following bench testing was performed to ensure that the
UNIDRIVE S III ENT system meets its design specification Inspection of rotation speed and torque Bench testing demonstrated substantial equivalence to the
predicate device. |
| Clinical
Performance Data: | Clinical testing was not required to demonstrate the substantial
equivalence to the predicate device. Non-clinical bench testing
was sufficient to assess safety and effectiveness and to
establish the substantial equivalence of the modifications. |
| Substantial
Equivalence: | The conclusions drawn from the nonclinical test such as the
risk evaluation on the modification of the system, biological
evaluation summary, cleaning and sterilization summary
demonstrated that the subject device is as safe and as effective
as the predicate device. Both systems also comply with
identical standards and safety testing, where applicable.
As such, we concluded that the substantial equivalence of the
subject and the predicate device has been met, and the
differences between the subject and predicate do not raise new
questions of safety and effectiveness. |
4
Image /page/4/Picture/0 description: The image displays the logo for "STORZ KARL STORZ – ENDOSKOPE". The word "STORZ" is written in large, bold, blue letters. Below it, the words "KARL STORZ – ENDOSKOPE" are written in smaller, blue letters. The logo appears to be for a medical company.
5
Image /page/5/Picture/0 description: The image is a logo for Karl Storz Endoskope. The word "STORZ" is in large, bold, blue letters. Below that, in smaller blue letters, is the phrase "KARL STORZ - ENDOSKOPE".