(27 days)
Not Found
No
The summary describes a motorized surgical device system for cutting and removing tissue and bone. There is no mention of AI, ML, image processing, or any data-driven decision-making capabilities.
No
The device is described as a surgical device system intended to shave, debride, cut tissue, and remove bone during surgical procedures, not to provide therapy.
No
Explanation: The device is described as a "motorized, reusable surgical device system" intended for "shaving, debriding, or cutting tissue" and "controlled cutting and removal of bone" during surgical procedures. These functions are therapeutic/interventional, not diagnostic.
No
The device description explicitly states it is a "motorized, reusable surgical device system" and mentions hardware components like "Shaver," "Drill," and "control unit." This indicates it is a physical device system, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "motorized, reusable surgical device system, intended for use by qualified surgeons to shave, debride, or cut tissue" or "provide controlled cutting and removal of bone" during surgical procedures. This describes a surgical instrument used on the patient's body, not a device used to test samples from the body (which is the definition of an IVD).
- Device Description: The description reinforces that it's a "motorized, reusable surgical device system" used in conjunction with various surgical tools.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), performing diagnostic tests, or providing information about a patient's health status based on sample analysis.
Therefore, this device falls under the category of a surgical instrument or system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The KSEA Paranasal Sinus Shaver, Micro Shaver or Stammberger-Castelnuovo DrillCut-X Shaver in conjunction with the UNIDRIVE ENT control unit is a motorized, reusable surgical device system, intended for use by qualified surgeons to shave, debride, or cut tissue during Head, Neck, ENT and Otoneurological surgical procedures. The KSEA Stammberger-Sachse Intranasal Drill or the INTRA Drill in conjunction with the UNIDRIVE ENT control unit is a motorized, reusable surgical device system, intended for use by qualified surgeons to provide controlled cutting and removal of bone during Head, Neck, ENT and Otoneurological surgical procedures.
Product codes (comma separated list FDA assigned to the subject device)
ERL
Device Description
The UNIDRIVE ENT System is a motorized, reusable surgical device system that can be used in conjunction with Stammberger Paranasal Sinus Shaver, Micro Shaver, Stammberger-Castelnuovo DrillCut-X Shaver, Stammberger-Sachse Intranasal Drill and INTRA Drill.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Head, Neck, ENT, 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)
Not Found
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 shows a black and white graphic of the word "STOLPER". The letters are stylized with a double-line effect, giving them a retro or vintage appearance. The word is horizontally oriented, and the contrast between the black background and white letters makes it stand out.
Karl Storz Endoscopy-America, Inc.
600 Cornorate Pointe 5th Flo Culver City, California 90230-7600 Phone 310 338 8100
Fax 310 410 5527
DEC 1 9 2005
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 Drive
Culver City, CA 90230
(310) 338-8100 |
|------------------------|---------------------------------------------------------------------------------------------------------------|
| Contact: | Yvonne Fernandez/Sr. Regulatory Affairs Specialist |
| Device Identification: | Common Name: Surgical ENT Shaver/ENT Drill
Trade Name: UNIDRIVE ENT & Accessories |
Indications: The KSEA Paranasal Sinus Shaver, Micro Shaver or Stammberger-Castelnuovo DrillCut-X Shaver in conjunction with the UNIDRIVE ENT control unit is a motorized, reusable surgical device system, intended for use by qualified surgeons to shave, debride, or cut tissue during Head, Neck, ENT and Otoneurological surgical procedures. The KSEA Stammberger-Sachse Intranasal Drill or the INTRA Drill in conjunction with the UNIDRIVE ENT control unit is a motorized, reusable surgical device system, intended for use by qualified surgeons to provide controlled cutting and removal of bone during Head, Neck, ENT and Otoneurological surgical procedures.
Device Description: The UNIDRIVE ENT System is a motorized, reusable surgical device system that can be used in conjunction with Stammberger Paranasal Sinus Shaver, Micro Shaver, Stammberger-Castelnuovo DrillCut-X Shaver, Stammberger-Sachse Intranasal Drill and INTRA Drill.
Substantial Equivalence: The KSEA Stammberger Paranasal Sinus Shaver, Micro Shaver, Stammberger-Castelnuovo DrillCut-X Shaver, Stammberger-Sachse Intranasal Drill and INTRA Drill are substantially equivalent to the predicate devices since the basic features, design and intended uses are similar. The minor differences in design and dimensions between the subject devices and the predicate devices raise no new issues of safety and effectiveness, as these design differences have no effect on the performance, function or intended use of these devices.
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| TABLE 1: SUBSTANTIAL EQUIVALENCE TABLE FOR ENT SHAVER BLADES AND CUTTERS |
|---|
| Device | UNIDRIVE ENT Shaver
Handpieces | UNIDRIVE II/II PLUS
(K003994) Paranasal Sinus
Shaver Handpiece | XPS 3000 (K041413)
Magnum II/M4 Microresector |
|---------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Basic Features | Handpiece w/Suction
Control Unit w/Footswitch | Same | Same |
| | Straight or Angled (90°) Design | Angled (90°) Design | Straight/"Sculpted" |
| Maximum Speed (rpm)/
Modes | 3,500 - 12,000/FWD-REV;
3,000 - 7,000/OSC | 3,000/FWD;REV;OSC | 15,000/FWD;REV
5,000/OSC |
| Blade/
Sinus Burr Dimensions | O.D.: 3.0 - 5.0 mm
Lengths: 12 cm | O.D.: 2.0 - 4.0 mm
Lengths: 7-12 cm | O.D.: 2.0 - 6.0 mm
Lengths: unknown |
| Autoclavable | Yes | Yes | Yes |
| Body Contacting
Material | Stainless steel | Same | Stainless steel and medical polymer |
| Intended Use | To shave, debride or cut tissue
during Head, Neck, ENT and
Otoneurological surgical
procedures. | To shave, debride or cut
tissue during ENT endoscopic
surgical procedures. | Shaving, debridement and cutting
of soft tissue and bone during
Head, Neck, ENT, Otoneurological,
Aesthetic and Arthroscopic surgical
procedures. |
| | TABLE 2: SUBSTANTIAL EQUIVALENCE TABLE FOR STAMMBERGER SACHSE INTRANASAL DHILL | | |
| Device | JNIDRIVE ENT | UNIDRIVE II/II PLUS | XPS 3000 Bone Drill (K00222 |
| | ntranasal Dril | K003994) Intranasal Dril | |
| asic Features | andpiece w/Suction | Same | Same |
| | Control Unit w/Footswitch | Same | Same |
| | lesigr
Straight or Angled (90°) D | Angled (90°) Design | Angled Desigr |
| laximum Speed (rpm | 60,000 | 20,000 | 80,000 |
| Abrader Dimension | Diameters: 2.5 - 5.0 mm | Diameters: 2.5 - 3.0 mn | Unavailable |
| utoclavable | Yes | Yes | Yes |
| | | Same | Titanium; aluminum coated with |
| Body Contacting Material | | | fluoroplastic/carbide; diamond dust |
| ntended Use | Surgical grade stainless steel; diamond dust covered heads To provide contriled contribute and To provide contrilled contribution and Neck, ENT and Otone undering and other a | To provide controlled | To provide controlled shaving, debridement |
| | | cutting and removal of bone | cutting and removal of soft and bone tissue |
| | | issue during ENT | during Head, Neck, ENT and |
| | surgical procedures. | procedures | Otoneurological surgical procedure |
| | | | |
| Device | UNIDRIVE ENT
INTRA Drill Handle | UNIDRIVE II/III PLUS (K003994)
ENT Drill | XPS 3000 Bone Drill (K002224) |
| Basic Features | Handpiece w/Suction
Control Unit w/Footswitch
Angled (90°) Design | Same
Same
Straight or Angled Design | Same
Same
Angled Design |
| Maximum Speed (rpm) | 40,000 | 40,000 | 80,000 |
| Abrader/Burr | | Diameters: 0.6 - 7.0 mm | Unavailable |
| Dimensions | Diameters: 0.6 - 7.0 mm
Lengths: 5.7-12.5 cm | Length: 5.7-12.5 cm | |
| Body Contacting
Material | Surgical grade stainless steel;
tungsten carbide; diamond dust | Surgical grade stainless steel;
tungsten carbide; diamond dust | Titanium; aluminum coated with
fluoroplastic/carbide; diamond
dust |
| Intended Use | To provide controlled cutting and
removal of bone tissue during
Head, Neck, ENT and
Otoneurological surgical
procedures. | To provide controlled cutting and
removal of bone tissue during ENT
endoscopic surgical procedures. | To provide controlled shaving,
debridement, cutting and
removal of soft and bone tissue
during Head, Neck, ENT and
Otoneurological surgical
procedures. |
ANASAI DRIL
2
table 3: Substantial Equivalence Table For DRILLS
Signed:
Yvonne Fernandez
Yvonne Fernandez
Sr. Regulatory Affairs Specialist
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three wavy lines representing the feathers.
Public Health Service
DEC 1 9 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Karl Storz Endoscopy-America, Inc. c/o Ivonne Fernandez Sr. Regulatory Affairs Specialist 600 Corporate Pointe 5th Floor Culver City, California 90230
Re: K053262
Trade/Device Name: KSEA Unidrive ENT System and Accessories 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: November 18, 2005 Received: November 22, 2005
Dear Ms. Fernandez:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for association 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 r ou may, diere, mains of the Act include requirements for annual registration, listing of general oonline profition 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 may oc subject to back as back 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 r lease oc acrised that i Dr bratian that your device complies with other requirements of the Act that I Dr hand statutes and regulations administered by other Federal agencies. You must of any I cuolul statures than oggaments, including, but not limited to: registration and listing comply with an the Hee req (21 CFR Part 801); good manufacturing practice requirements as set (2) CFR Part 807), acceming (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 - Ivonne 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 prematicated predicated. The aclassification 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 It you attire of Compliance at (301) 827-8910. Also, please note the regulation entitled, Contact the Ories of Colling of Colling the mart 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general intermational 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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Image /page/5/Picture/0 description: The image shows a black rectangular object with the words "STORZ" and "KARL STORZ ENDOSCOPE" written in white. The word "STORZ" is written in a stylized font, with the letters overlapping each other. The words "KARL STORZ ENDOSCOPE" are written in a simpler font, and are located below the word "STORZ". There is a white circle on the left side of the object.
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) Number (if known): K053262
Device Name: UNIDRIVE ENT System and Accessories
Indications for Use:
The STAMMBERGER Paranasal Shaver 90° Handpiece, the straight Micro-The OTAMMBERGER or the STAMMBERGER-CASTELNUOVO DrillCut-X Shaver Shaver Handpiece in conjunction with the UNIDRIVE ENT control unit is a motorized, reusable surgical device system, intended for use by qualified surgeons to shave, reasublo burgiour as not of the of the and Otoneurological surgical procedures.
The KSEA Stammberger-Sachse Intranasal Drill or ENT Drill in conjunction with the UNIDRIVE ENT control unit is a motorized, reusable surgical device system, intended for use by qualified surgeons to provide controlled cutting, drilling, intonious of as a removal of bone during Head, Neck, ENT and Otoneurological surqical 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) | |
| OR Over-The-Counter Use: | |
| (Optional Format 1-2-96) |
(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises
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