(56 days)
No
The device description and intended use clearly describe a physical silicone strip used as a dressing, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes.
The device is intended to reduce the risk of adhesion, prevent canal granulation and polyp formation, and temporarily cover the tympanic membrane after surgical procedures in the middle ear, all of which are therapeutic effects.
No
Explanation: The device, KURZ Silicone Strips, is described as a post-surgical dressing for the tympanic membrane to prevent adhesion and aid healing. Its function is entirely therapeutic and preventative, not diagnostic.
No
The device description clearly states the device is manufactured from a medical grade silicone elastomer and is a physical strip, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The KURZ Silicone Strips are physical implants placed in the body (specifically, the ear canal and over the tympanic membrane) during or after surgery. Their function is mechanical – to reduce adhesion, prevent granulation, and cover the tympanic membrane.
- Lack of Specimen Analysis: The device does not analyze any biological specimens. It is a physical barrier and support.
Therefore, the KURZ Silicone Strips fall under the category of a surgical implant or device used in a surgical procedure, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
KURZ Silicone Strips are placed over the tympanic membrane after surgical procedures in the middle ear to reduce the risk of adhesion to the surgical packing and to aid in the prevention of canal granulation and polyp formation. Using conventional otologic pliers and tweezers, the three sterile strips contained in one pouch are placed one over the other covering the tympanic membrane in a star-shaped pattern, with the atraumatic, rounded end toward the anterior meatal flap. The center of the strip is inserted to overly the tympanic membrane.
Once the wound has healed, the silicone strips are removed from the auricular canal by the physician, should they not be expelled with the tamponage or upon disintegration of the gelatinous tamponage. This usually takes place after 10-21 days.
KURZ Silicone Strips are designed to temporarily cover the tympanic membrane after surgical procedures in the middle ear.
Product codes
KHJ
Device Description
KURZ Silicone Strips are manufactured from a medical grade silicone elastomer cut to size specifically for use within the external ear canal following ear surgery. The pliable, soft consistency of the silicone strips adapts itself to the shape of the auricular canal without further shaping by the physician, which saves valuable time in the operating room.
KURZ Silicone Strips are intended for single use and are provided sterile. They require no further processing. They will be supplied transparent, white or transparent with blue stripes. Application, use and technical characteristics of the three presentations are identical. Choice of one or the other is entirely a matter of personal preference of the operating surgeon. Some surgeons prefer the transparent silicone strip, since the healing process can be checked without removing the dressing. Others prefer the white silicone strip, since they find it easier to see and handle. The transparent strips imprinted with blue stripes combine both advantages. The healing process can be observed through the transparent parts of the silicone, while the blue stripes make the silicone strips easily visible.
Dimensions: 0.12 x 45 x 6 mm (thickness, length, width)
Colors:
- Transparent
- White
- Transparent with blue stripes
Packaging: Each package contains ten sterile (10) pouches with three strips/pouch
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
external ear canal, middle ear, tympanic membrane, auricular canal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician / Operating room
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)
The silicone elastomer, coloring agents and packaging material were tested for biocompatibility in conformance with international and FDA-recognized standards, including the FDA "Blue Book Memorandum" based on ISO 10993 Part 1 "Biological Evaluation of Medical Devices". KURZ Silicone Strips present no safety risks or hazards and are safe and effective for the indicated use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 874.3620 Ear, nose, and throat synthetic polymer material.
(a)
Identification. Ear, nose, and throat synthetic polymer material is a device material that is intended to be implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck. The device is used, for example, in augmentation rhinoplasty and in tissue defect closures in the esophagus. The device is shaped and formed by the suregon to conform to the patient's needs. This generic type of device is made of material such as polyamide mesh or foil and porous polyethylene.(b)
Classification. Class II.
0
'JAN 3 0 2004
K033796
Section 2
510(k) SUMMARY of Safety and Effectiveness
(as required by Section 807.92)
| Applicant: | Heinz Kurz GmbH Medizintechnik
Tübinger Str. 3
D-72144 Dusslingen
Germany
Tel. 011-49-7072-91790
Fax 011-49-7072-917979
E-mail: info@kurzmed.de |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Angelika Scherp
Business Support International
Amstel 320-1
1017AP Amsterdam
The Netherlands
Tel. 011-31-20-428-9591
Fax 011-31-20-428-9429
E-mail: bsi@xs4all.nl |
| Proprietary Name: | KURZ Silicone Strips |
| Common Name: | Silicone Strips |
| Classification Name: | Elastomer, Silicone Block |
| Substantial
Equivalence: | KURZ Silicone Strips are substantially equivalent in
function, performance and material to Silicone Elastomer Sheeting
marketed by Specialty Surgical Products, Inc., K974653. |
| Device Description:
General | KURZ Silicone Strips are manufactured from a medical grade
silicone elastomer cut to size specifically for use within the external
ear canal following ear surgery. The pliable, soft consistency of the
silicone strips adapts itself to the shape of the auricular canal
without further shaping by the physician, which saves valuable
time in the operating room.
KURZ Silicone Strips are intended for single use and are provided
sterile. They require no further processing. They will be supplied
transparent, white or transparent with blue stripes. Application, use
and technical characteristics of the three presentations are
identical. Choice of one or the other is entirely a matter of personal
preference of the operating surgeon. Some surgeons prefer the
transparent silicone strip, since the healing process can be
checked without removing the dressing. Others prefer the white
silicone strip, since they find it easier to see and handle. The
transparent strips imprinted with blue stripes combine both |
1
K033796
| | advantages. The healing process can be observed through the
transparent parts of the silicone, while the blue stripes make the
silicone strips easily visible. | | | |
|-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|
| Dimensions | 0.12 x 45 x 6 mm (thickness, length, width) | | | |
| Colors | 1. Transparent
2. White
3. Transparent with blue stripes | | | |
| Packaging | Each package contains ten sterile (10) pouches with three
strips/pouch | | | |
| Intended Use: | KURZ Silicone Strips are placed over the tympanic membrane
after surgical procedures in the middle ear to reduce the risk of
adhesion to the surgical packing and to aid in the prevention of
canal granulation and polyp formation. Using conventional otologic
pliers and tweezers, the three sterile strips contained in one pouch
are placed one over the other covering the tympanic membrane in
a star-shaped pattern, with the atraumatic, rounded end toward the
anterior meatal flap. The center of the strip is inserted to overly the
tympanic membrane. | | | |
| | Once the wound has healed, the silicone strips are removed from
the auricular canal by the physician, should they not be expelled
with the tamponage or upon disintegration of the gelatinous
tamponage. This usually takes place after 10-21 days. | | | |
| Predicate Device: | KURZ Silicone Strips are substantially equivalent in material,
function and performance to Silicone Elastomer Sheeting marketed
by Specialty Surgical Products, Inc. However, they are precut and
rarely need additional shaping. | | | |
| Sterilization: | KURZ Silicone Strips are sterilized by low-temperature gas plasma
to avoid the degrading effects of steam or the residues of ethylene
oxide. The sterility assurance level (SAL) for the KURZ Silicone
Strips will be 10-6. | | | |
| Biocompatibility: | The silicone elastomer, coloring agents and packaging material
were tested for biocompatibility in conformance with international
and FDA-recognized standards, including the FDA "Blue Book
Memorandum" based on ISO 10993 Part 1 "Biological Evaluation
of Medical Devices". KURZ Silicone Strips present no safety
risks or hazards and are safe and effective for the indicated use. | | | |
| Information Bearing on Safety and Effectiveness | [807.92(b))3)]
There are no additional characteristics known that should
adversely affect the safety and effectiveness of KURZ Silicone
Strips. The results of design validation raise no issues of
safety and effectiveness. | | | |
2
K033796
SE COMPARISON TABLE
| | KURZ | SPECIALTY
SURGICAL
PRODUCTS
K974653 | AESTHETIC &
RECONSTRUCTIVE
TECHNOLOGIES
K022223 | SE |
|---------------------|----------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|-----------------------------------------------------------------|-----|
| Material | Silicone sheeting | Silicone sheeting | Silicone sheeting | YES |
| Sterility | Sterile | Not labeled | Sterile | YES |
| Indications for Use | Temporary protective
sheathing for
the external ear
canal | Temporary protective
sheathing for
the external ear
canal | Temporary protective
sheathing for the external
ear canal | YES |
| Measurements | 0.12 x 45 x 6 mm | Cut to size by user | Cut to size by user | YES |
| Reusable | No | No | No | YES |
| Coloring Agents | 1% Titanium
Dioxide NuSil
MED3-4502
(USP Grade)
Silicone Coating /
Marking Ink
NuSil R1008-7 | Not labeled | Not labeled | |
| Biocompatible | Yes | Yes | Yes | YES |
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three abstract human figures or waves, stacked vertically.
JAN 3 0 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Heinz Kurz GmbH Medizintechnik c/o Angelika Scherp Business Support International Amstel 320-1 1017 AP Amsterdam The Netherlands
Re: K033796
Trade/Device Name: KURZ Silicone Strips Regulation Number: 21 CFR 874.3620 Regulation Name: Ear, nose, and throat synthetic polymer material Regulatory Class: Class II Product Code: KHJ Dated: December 3, 2003 Received: December 5, 2003
Dear Ms. Scherp:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your because of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce use suned in also encreated of the Medical Device Amendments, or to devices that proble to thay 20, 1978, and cordance 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 therefore, mainer the 00 1.000 include requirements for annual registration, listing of devices, good ecanofacturing 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 n your device to such additional controls. Existing major regulations affecting your device can be may be subject to sain adata 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 1 tease of advisod that 127 rination that your device complies with other requirements of the Act or that Federal statutes and regulations administered by other Federal agencies. You must comply with ally t oderal blankted une registration of 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.
4
Page 2 - Angelika Scherp
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 (301) 594-4613. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
A helyl 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
Enclosure
5
Traditional 510(k) ENT Devices Branch HFZ-460
510(k) Number
K033 796
Device Name
Silicone Strips
INDICATIONS FOR USE
KURZ Silicone Strips are designed to temporarily cover the tympanic AORE Officent after surgical procedures in the middle ear.
Signature
(Division Sign-Off) Division o onthalmic Ear, Nose and ithroat Devis
510(k) Number K033796
(Please Do NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per CFR 801 109) OR
Over-The-Counter Use
(Optional Formal 1-2-96)
A - 1