(16 days)
Not Found
No
The summary describes a disposable tubing set for an irrigation system, with no mention of AI or ML capabilities.
No.
The device is a tubing set used for controlled infusion of sterile irrigant solution during surgical procedures, which is an accessory to a therapeutic system, but not therapeutic itself.
No
The device is described as a disposable tubing set for controlled infusion of sterile irrigant solution during ENT endoscopic surgical surgery, which is a therapeutic/surgical function, not a diagnostic one.
No
The device description explicitly states it is a "Disposable Tubing Set," which is a physical hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the controlled infusion of sterile irrigant solution during ENT endoscopic surgical surgery. This is a surgical procedure performed on a patient, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The device is a tubing set used with a system for surgical irrigation. This aligns with a surgical accessory, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
IVDs are devices intended to be used in vitro (outside the body) for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The MTP Unidrive® II Plus Disposable Tubing Set is intended to be utilized with the Karl Storz Unidrive® II Plus System for the controlled infusion of sterile irrigant solution during ENT endoscopic surgical surgery.
Product codes
ERL
Device Description
The MTP Unidrive® II Plus Disposable Tubing Set is utilized with the Karl Storz Unidrive® II Plus System. It is sold as sterile and single use device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ENT
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
$\underline{K}$OH811
Image /page/0/Picture/1 description: The image shows the date JUN 19 2002 on the left side. On the right side of the image is a logo that says "mtp" in a stylized font. Below the logo, the words "technical medical promotion" are written in a smaller font. The words "medical" and "promotion" are underlined.
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 MTP's knowledge.
| Application: | MTP Medical Technical Promotion GmbH
P.O. Box 4529
d-78510, Tuttlingen
telephone: +49/7461/96630-25
(310) 558-1500 | |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------|--|
| Contact: | James A. Lee, Ph.D.
(310) 410-2769 | |
| Device Identification: | Common Name:
Disposable Tubing Set | |
| | Trade Name: (optional)
Unidrive® II Plus Disposable Tubing Set | |
Indication: The MTP Unidrive® II Plus Disposable Tubing Set is intended to be utilized with the Karl Storz Unidrive® II Plus System for the controlled infusion of sterile irrigant solution during ENT endoscopic surgical surgery.
Device Description: The MTP Unidrive® II Plus Disposable Tubing Set is utilized with the Karl Storz Unidrive® II Plus System. It is sold as sterile and single use device.
The MTP Unidrive® II Plus Disposable Tubing Set is Substantial Equivalence: substantially equivalent to the predicate device since the basic features and intended uses are identical.
Signed:
James A. Lee, Ph.D.
1
KO24811
Image /page/1/Picture/1 description: The image shows a logo with the letters 'mtp' stacked on top of each other. The 't' is in a black square, and below the letters, the words 'technical medical promotion' are written in a smaller font. The word 'medical' is underlined, and the word 'promotion' is enclosed in a square.
SUBSTANTIAL EQUIVALENCE TABLE FOR MTP Unidrive® II Plus DISPOSABLE TUBING SET
| Manufacturer | MTP | KSEA(K003994) |
|---|---|---|
| Components | Irrigation tubing, roller pump tubing, tubing connectors, and a irrigation bag piercing spike | Same |
| Irrigation tubing lengths | Input: 150 cm | |
| Output: 310 cm | Same | |
| Tubing, connector, and spike materials | Medical grade elastomer and plastics | Same |
| Sterile, Single Use | Yes | Same |
| Sterilization Method | Ethylene Oxide | Same |
| Packaging | Peel pouches | Same |
| Intended Use | For use with the Karl Storz Unidrive® II Plus System for the controlled infusion of sterile irrigant solution during ENT endoscopic surgical surgery | Same |
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a symbol. The symbol consists of a stylized caduceus, which is a staff entwined by two snakes, often associated with medicine and healthcare. The seal is in black and white.
JUN 1 9 2002
Medical Technical Promotion GmbH c/o James Lee, Ph.D. 600 Corporate Pointe Culver City, CA 90230
Re: K021811
Trade/Device Name: MTP Unidrive® II Plus Disposable Tubing Set Regulation Number: 21 CFR 874.4250 Regulation Name: ENT Electric or Pneumatic Surgical Drill Regulatory Class: Class II Product Code: ERL Dated: May 31, 2002 Received: June 3, 2002
Dear Mr. Lee:
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.
3
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html
Sincerely yours,
A. Ralph Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
4
Image /page/4/Picture/0 description: The image shows a logo with the letters "mtp" in a stylized font. The letters are arranged in a way that the "t" is in a black box, and the "m" and "p" are in outlined boxes. Below the letters, the words "technical medical promotion" are written in a smaller font. The background of the image is a textured pattern.
510(k) Number (if known): KOJ | 8 ||
Device Name: MTP Unidrive® II Plus Disposable Tubing Set
Indication for Use: The MTP Unidrive® II Plus Disposable Tubing Set is intended to be utilized with the Karl Storz Unidrive® II Plus System for the controlled infusion of sterile irrigant solution during ENT endoscopic surgical surgery.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) OR Over-the-Counter Use: _ Prescription Use: (Per 21 CFR 801.109) (Optional Format 1-2-96)
Kluu Bahr
Division Sign-Off) Division of Ophthalmic Ear, Nose and Throat Devis
510(k) Number K021811
003