(24 days)
K1, K2
No
The device description focuses on the mechanical design and materials of a stapes prosthesis for otosclerosis surgery. There is no mention of AI, ML, image processing, or any software-based functionality that would typically incorporate these technologies. The performance studies compare the device to existing mechanical prostheses.
Yes
The device is a prosthesis designed to replace the stapes after stapedotomy and stapedectomy, which clearly indicates a therapeutic intent to restore or improve the patient's ear function after a medical procedure.
No
Explanation: The device is described as a "Funnel-shaped titanium stapes prosthesis (piston)" used for the "Replacement of the stapes after stapedotomy and stapedectomy." This indicates a therapeutic or reconstructive function, not a diagnostic one.
No
The device description clearly describes a physical, implantable titanium prosthesis (piston) used in stapes surgery, which is a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Function: The provided description clearly states that this device is a stapes prosthesis, which is a physical implant used in surgery to replace a bone in the middle ear. It is a surgical device, not a diagnostic test performed on a sample.
- Intended Use: The intended use is for surgical replacement of the stapes, not for diagnosing a condition.
Therefore, based on the provided information, this device falls under the category of a surgical implant, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Like the SE devices, the KURZ stapes prostheses, Models Schobel + Schobel-Causse, are designed for replacement of the stapes after stapedotomy or stapedectomy in otosclerosis surgery.
Model Schobel-Causse is indicated for first-time procedures only (placement of stapedius tendon in U-shaped hook), while Model Schobel can also be used in secondary surgery.
Otosclerosis Surgery: Replacement of the stapes after stapedotomy and stapedectomy.
SCHOBEL: Initial and secondary surgery
SCHOBEL-CAUSSE: Initial surgery with retention of stapedial muscle reflex.
Product codes
77 ETB
Device Description
Funnel-shaped titanium stapes prosthesis (piston) which is articulated to the lenticular process of the long limb of the incus. Thus, neither a loop nor a frame are necessary for linking the prosthesis.
The Schobel-Causse model is equipped with a process perpendicular to the piston stem. The stapedius reflex is reconstructed by latching the stapedius tendon into the u-shaped process end. (indicated for first-time procedures).
The shaft of both prosthesis models (Schobel + Schobel-Causse) is placed on the membrane (vein or fascia) in the oval window. With this technique, the graft interposition serves as a replacement of the annular ligament, discourages the piston shaft from pressing into the saccule, and effectively inhibits the development of possible perilymphatic fistula.
Mentions image processing
The image quality may be impeded or blurred in direct vicinity of the implant.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
middle ear / stapes / incus / oval window
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Qualified medical personnel trained in middle ear reconstructive surgery.
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
Clinical results to date have shown that KURZ titanium middle-ear implants compare favorably with SE devices regarding safety and effectiveness.
Key Metrics
Not Found
Predicate Device(s)
K1, K2
Reference Device(s)
K910685, K925443, K950885, K950886, K950887, K950984, K952481, K872112, K964909
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 874.3450 Partial ossicular replacement prosthesis.
(a)
Identification. A partial ossicular replacement prosthesis is a device intended to be implanted for the functional reconstruction of segments of the ossicular chain and facilitates the conduction of sound wave from the tympanic membrane to the inner ear. The device is made of materials such as stainless steel, tantalum, polytetrafluoroethylene, polyethylene, polytetrafluoroethylene with carbon fibers composite, absorbable gelatin material, porous polyethylene, or from a combination of these materials.(b)
Classification. Class II.
0
SEP 1 6 1999
Heinz Kurz GmbH · Medizintechnik · Postfach 39 · D-72142 Dußlingen
KA92839
1
510(k) SUMMARY of Safety and Effectiveness
510(K) - 77 ETB
SE Comparison Table
Heinz Kurz GmbH Medizintechnik
As required by Section 807.92
| 2.1 | Submitter: [807.92 (a)(1)]
Heinz Kurz GmbH Medizintechnik | | |
|-----|--------------------------------------------------------------|-------|--------------------------------------------|
| | Tuebinger Str. 3 | Tel. | +49-7072-91 79 0 |
| | D-72144 Dusslingen | Fax | +49-7072-91 79 79 |
| | Germany | eMail | tkurz@kurzmed.de
usteinhardt@kurzmed.de |
| 2.2 | Contact Person: [807.92 (a)(1)] | | |
| | Dagmar S. Maeser | | |
| | Business Support International | | |
| | Amstel 320-I | Tel. | +31-20-428 95 91 |
| | 1017 AP Amsterdam | Fax | +31-20-428 94 29 |
2.3 Date Summary Prepared: [807.92 (a)(1)] August 18, 1999
The Netherlands
| 2.4 | Device Names: [807.92 (a)(2)] | |
|---|---|---|
| Proprietary | Socket Stapes Piston w/o Loop (Schobel) + | |
| (Schobel-Causse) | ||
| Common | Partial Ossicular Replacement Prosthesis, | |
| Stapes Piston | ||
| Classification | Middle Ear, Prosthesis, Partial Ossicular | |
| Replacement |
Image /page/0/Picture/13 description: The image shows the word "KURZ" in a stylized font. The letters are thick and sans-serif. A curved line is below the word, resembling a smile or an arc, and it is positioned to give the impression of a face or logo.
Heinz Kurz GmbH Medizintechnik
Hausanschrift: Tübinger Straße 3 D-72144 Dußlingen
Telefon (0 70 72) 91 79-0 Telefax (07072) 9179-79
Geschäftsführer: Heinz Kurz Traute Kurz-Butzki USt.-Id. Nr. DE 811570328
Volksbank Steinlach-Wiesaz eG (BLZ 640 618 54) Konto-Nr. 70 150 001 Baden-Württembergische Bank Tübingen (BLZ 641 200 30) Konto-Nr. 120 140 2300
Amtsgericht Tübingen HRB 1424
1
Reason for Submission: [807.81(2)] 2.5 New Device
2.6 Predicate Devices [807.92(a)(3)]
| Manufacturer | |||
|---|---|---|---|
| Smith & Nephew Richards | XOMED | ||
| K1 | K2 | ||
| Proprietary Names | Catalog #'s | Catalog #'s | |
| Fluoroplastic Pistons | 14-0xxx | Causse TEF Piston | |
| Cup Pistons - Stainless Steel | 14-2xxx | - PTFE Polymer | 11-563xx |
| Lippy Modified Stapes Prosth. | Causse TEF Piston | ||
| - Stainless Steel | 14-211x | Large Loop | |
| Richards Bucket Handle Prosth. | - Teflon | 11-290xx | |
| - Stainless Steel | 14-20xx | Robinson | |
| - Fluoroplastic | 14-21xx | - Teflon | XO-240x |
| Shea Cup Pistons | 'Cupped Designs' | ||
| - Fluoropl. Left/Right Ear | 14-04xx | - Stainless Steel | 11-33xxx |
| Shea Platinum/Fluoropl. | 14-06xx | Bailey/Pappas Modified | |
| - Stainless Steel | 11-564xx |
2.7 Device Description: [807.92(a)(4)]
Funnel-shaped titanium stapes prosthesis (piston) which is articulated to the lenticular process of the long limb of the incus. Thus, neither a loop nor a frame are necessary for linking the prosthesis.
The Schobel-Causse model is equipped with a process perpendicular to the piston stem. The stapedius reflex is reconstructed by latching the stapedius tendon into the u-shaped process end. (indicated for first-time procedures).
The shaft of both prosthesis models (Schobel + Schobel-Causse) is placed on the membrane (vein or fascia) in the oval window. With this technique, the graft interposition serves as a replacement of the annular ligament, discourages the piston shaft from pressing into the saccule, and effectively inhibits the development of possible perilymphatic fistula.
2.8 Intended Use: 1807.92 (a)(5)]
Like the SE devices, the KURZ stapes prostheses, Models Schobel + Schobel-Causse, are designed for replacement of the stapes after stapedotomy or stapedectomy in otosclerosis surgery.
Model Schobel-Causse is indicated for first-time procedures only (placement of stapedius tendon in U-shaped hook), while Model Schobel can also be used in secondary surgery. 3
It could not be determined, which (or if any) of the following submissions cleared SE devices for commercial distribution or if they fall under the preamendment ruling:
K910685, K925443, K950885, K950886, K950887, K950984, K952481
2 It could not be determined if K872112 or K964909 contain SE devices or if they are possibly pre-amendment.
3 As late as 10-15 years after initial procedures, secondary surgery is sometimes indicated after implanting of
2
Difference in Design and Technological Characteristics when 2.9 Compared to SE Devices [ 807.92 (a)(6)]
The KURZ Stapes Cup Pistons are manufactured exclusively of highgrade surgical titanium while the various models of SE devices are made of fluoroplastic, stainless steel and a combination of fluoroplastic and titanium.
The design is very similar. Both KURZ and SE devices consist of a straight stem, the piston, topped by a sort of cup (S+N, Xomed) or funnel-shaped socket (KURZ). The major difference lies in SE devices requiring a loop for fastening to the incus process while the KURZ pistons are articulated.
The piston diameter for KURZ devices is 0.4 mm and in SE devices ranges from 0.3 mm to 0.8 mm.
2.10 Discussion of Safety and Effectiveness [807.92(b)]
Clinical results4 to date have shown that KURZ titanium middle-ear implants compare favorably with SE devices regarding safety and effectiveness. The Schobel/Schobel-Causse implants exhibit the following features:
2.10.1 Implant Length
KURZ implants are 3.5 - 4.5 mm long and come in 0.25 mm increments while the length of SE devices ranges from 4.0 - 6.0 (Xomed) and 3.5 - 6.0 (S&N) and -- with some exceptions - usually are in 0.5 mm steps.
Very precise fitting Benefit:
2.10.2 Fixation to Incus without Loop
The design corresponds with the anatomic structure of the ossicular chain. The socket-like piston top is articulated with the incus, eliminating the need for a wire loop or frame to assure fixation as is common with SE devices.
Eliminates loosening of loop (SE devices) with resulting Benefit: hearing loss and associated risks due to pressure at the incudal process such as atrophy, necrosis, detachment of incudal process). (s. Footnote 1)
3 As late as 10-15 years after initial procedures, secondary surgery is sometimes indicated after implanting of conventional pistons. The loop used for fastening the piston around the incudal process may cause atrophy of the bone which results in the implant coming loose. This may cause intermittent hearing problems depending on the ear pressure in the middle ear.
ব See Exhibit 2 for Intermediate Report on clinical investigation on titanium middle-ear implants in comparison to other materials.
3
2.10.3 Drastic Reduction of Perilymphatic Fistula or Necrosis Formation
If the surgeon follows the prescribed surgical technique, the formation of perilymphatic fistula or necrosis due to pressure at the incudal process can be avoided with high degree of certainty.
Substitution of Stapedial Annular Ligament ( Schobel + 2.10.4 Schobel-Causse)
Through placement of vein or fascia over vestibule. This is also practiced with SE device. Causse TEF from XOMED.
Maintenance of Stapedius Reflex Function (Schobel-2.10.5 Causse)
Although the method of attachment to the piston varies, like the Causse TEF piston from XOMED, the stapedius tendon is retained to preserve the stapedial muscle reflex:
Protection of inner ear from acoustic trauma; Benefits: 1.
-
- Improvement of patients' hearing in noisy environment;
-
- Patients can hear own voice more normally:
- Improvement of noise localization: 4.
- ട. Regulation of inner ear pressure
2.10.6 Biocompatibility
ASTM F67 medical grade titanium has a proven record of excellent biocompatibility.
2.10.7 MRI
Testing in a 0.5 Tesla nuclear magnetic resonance tomograph has revealed no implant movement and no adverse tissue effects attributable to MRI-generated heating. The image quality may be impeded or blurred in direct vicinity of the implant. To date, no report of adverse effects has come to the attention of the manufacturer.
2.10.8 Long-Term Clinical Results
Since 1979 the Schobel socket piston (without loop) design has been implanted with excellent hearing improvement and not a single case of incus necrosis, loosening of articulation with lenticular processus, or membrane penetration into the vestibulum. Until 1996, the piston material consisted of MACOR, a biocompatible glass ceramic product manufactured by RICHARDS. Since then, KURZ titanium prostheses have been used exclusively (see Exh. 3: Prof. H. Schobel, On Development of New Stapes Prosthesis in Otosclerosis Surgery)
2.10.9 Hearing Parameters
At least equal, if not better improvement of all hearing parameters can be achieved when compared to SE devices
4
2.11 Industry Standards: 1807.92 (d)]
KURZ certifies compliance with required ISO/EN/ASTM/AAM//ANSI and other device-related standards that apply to the manufacture, packaging, labeling, and sterilization, of subject devices including the validation of these processes.
2.12 Information Bearing on the Safety and Effectiveness:
[807.92 (b)(3)]
The KURZ titanium loop-less socket piston has the same intended use as predicate devices. The different material (tifanium) and design modification (socket top - no loop) do not adversely affect the safety and effectiveness of these implants, but rather enhance biocompatibility, implant stability and long-term problem-free fixation, and audio results achieved.
The results of design validation and clinical testing raise no new issues of safety and effectiveness.
2.13 COMPARISON WITH PREDICATE DEVICES
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | September 19 to 10 de 10 de 10 de 10 de 10 de 10 de 1
1/11/9
Company of Children
1 | and of the status of the county of the last
VAIIF | CHIT'
NEDUCW |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | | | |
5
| KURZ | XOMED | SMITH & NEPHEW | |
|---|---|---|---|
| Device | Socket Stapes Piston | ||
| w/o Loop | 1. Causse TEF-Pistons |
- Robinson
Stapedectomy - Cupped Pistons | 1. Fluoroplastic Pistons
- Cup Pistons
- Lippy Modified - Stainless
- Richards Bucket Handle
- Shea Cup
- Shea Platinum/Fluoroplastic |
| Model(s) | 1. Schobel 100650x - Schobel-Causse 100651x | 1. PTFE Polymer 11-563xx
Teflon 11-290xx - Teflon XO-24xx
- Stainless St. 11-33xxx
11-564xx | 1. Fluoroplastic 14-0xxx - Stainless 14-2xxx
- Stainless 14-211x
- Stainless 14-20xx
- Fluoroplastic 14-21xx
Fluoropl. L/R 14-04xx
Fluoroplastic w/
Platinum Loop 14-06xx |
| Intended
Use | Otosclerosis Surgery:
Replacement of Stapes
after Stapedectomy and
Stapedotomy | Otosclerosis Surgery:
Replacement of Stapes
after Stapedectomy and
Stapedotomy | Otosclerosis Surgery:
Replacement of Stapes
after Stapedectomy |
| Schobel | initial & secondary surgery | | |
| Schobel-Causse | initial; designed to receive
stapedius tendon to retain
stapedial muscle reflex | Causse TEF Pistons:
Retention of stapedial
tendon | |
| Material | ASTM F67 Medical Grade
Titanium | PTFE Polymer
Teflon
Stainless Steel | Fluoroplastic, Stainless Steel,
Fluoroplastic with Platinum Loop |
| Contra-
Indications | Known titanium allergy +
general preoperative
considerations, i.e.:
- acute & chronic
infections - general wound
healing disorders - alcohol, drugs, and
nicotine abuse | Not known | 1. When more conservative treat-
ment will suffice;
- When infection is present as
later scarring could cause
displacement of prosthesis; - Stapedectomy in better or only-
hearing ear not advisable due to
risk of cochlear deafness. |
| Adverse
Effects +
Interactions
MRI
X-ray +
Computed
Tomography
Microwave | • Harmless;
• The image quality may
be impeded near
implant
• Piston can be precisely
localized
• DO NOT EXPOSE
(s. WARNINGS below) | Not known | Complications include: - Postoperative sensorineural
deafness due to surgical
trauma and reparative granu
loma and perilymph fistula; - Labyrinthitis;
- Vertigo;
- Incus necrosis;
- Tympanic membrane perfor
- Otitis media;
- Prosthesis displacement;
- Recurrence of oval window
fixation. |
| Single Use
Device | YES | YES | YES |
| Provided
Sterile | YES | YES | YES |
| Sterilization
Method | Gamma Irradiation | Not known | Ethylene Oxide |
2 13 ... COMPARISON WITH PREDICATE DEVICES
6
COMPARISON WITH PREDICATE DEVICES 2.13 .
| KURZ | XOMED | SMITH + NEPHEW | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Resterilization | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Permitted | NO | Not known | YES - ETO, Autoclaving (250-254 F) and Flash Steam Autoclaving | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
| (270-274° F) depending on implant material | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Design | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Comparison | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Description | Titanium piston ( $\varnothing$ 0.4mm) with socket-like top for articulation to lenticular | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| incus process. | Piston with cup and wire loop for fastening around incus process |
'Cupped Piston Design' displays a notch in cup to 'cradle' incus arm. | Fluoroplastic and stainless steel piston ( $\varnothing$ 0.4 - 0.8 mm) with cup-like top and loop for fastening implant around incudal process. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Design
Comparison
Illustration
(Not shown at
same scale) | Image: Schobel, Image: Schobel-Causse | Image: Causse, Image: Robinson, Image: Cupped | Image: Fluoropl, Image: Classic, Image: Richard B., Image: Shea | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Dimensions
(mm) | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| - Lengths | 4.0 - 4.5 (0.25 mm increments)
Standard Length: 4.25 mm | Type $\varnothing$ Lengths CausseTEF 0.3 4.5-6.0 0.6 4.0-6.0 0.7 4.0-5.0 Robinson 0.6 4.0-4.5 Cupped P. 0.4 4.0-5.0 0.6 4.0-4.5 | | | | | | | | | | | | | | | | | | | | | | Type $\varnothing$ Lengths Fluoroplastic 0.6 3.5-6.0 0.8 4.0-6.0 Classic Stapes 0.4 4.0-5.0 0.6 4.0-5.0 Lippy Modif'd 0.4 3.65-5.1 Richard Bucket 0.4 3.5-5.0 0.6 3.5-5.0 Shea Cup 0.8 4.0-6.0 Shea Platinum/
Fluoroplastic 0.6 3.5-5.0 0.8 3.5-5.0 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| - Piston $\varnothing$ | 0.4 mm | Bailey/Pappas Model in 0.25 mm increments | With exception of Platinum/Fluoro-Plastic (0.25 mm) in 0.5 mm increments | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Length in 0.25 mm increments | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Weight5
Schobel
Schobel-Causse | 3.5 mg
4.0 mg | Not labeled | Not labeled; known example:
Fluoplastic-Platinum
Length 5 mm - $\varnothing$ 6 mm =5 mg | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Handling
Precautions | None | Not known | None labeled | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
5 These are approx. weights. Although the implants vary in length from 4.0 – 4.5, the weight differences are neglible and so tiny that they are of no practical consequence to surgeon or patient.
7
| KURZ | XOMED | SMITH & NEPHEW | |
|---|---|---|---|
| Substitution | |||
| of Stapedial | |||
| Annular | |||
| Ligament6 | YES | YES - with Causse-TEF | YES |
| Retention of | |||
| Stapedius | |||
| Tendon7 | YES - Only with Schobel- | ||
| Causse Model in | |||
| primary surgery | YES - with Causse-TEF | NO | |
| Surgical | |||
| Procedure | Enaural, Endomeatal or | ||
| Retroauricular: |
- Atticotomy to expose
ossicular chain; - Determine prosthesis
length prior to
interrupting chain;
Caution: Piston may not
project more than 0.5
mm into vestibule! - Cut incudostapedial joint
without damaging
incudal process; - Cut dorsal stapedial crus
just above and below
stapedius tendon
attachment; - Keep flap of vein or
fascia in standby
position; - With laser or diamond
drill cut 0.8 mm Ø hole
in footplate; - Close immediately with
vein or fascia; - While slightly lifting
incudal process, place
prosthesis on membrane
and connect socket to
incudal process. | Causse TEF
0.8mm hole is drilled in third
posterior of footplate. Large
vein graft interposition is used
to discourage piston shaft from
pressing upon saccule in case
of vacuum in middle ear.
Gently crimping the loop helps
secure it around incus. Seal is
made with small pieces of
perivenous tissue to secure
position.
Cupped Piston Design
Self-centering prostheses
eliminate need for wire
crimping around incus. | Not available |
COMPARISON WITH PREDICATE DEVICES 2.13
୧ Sealing of oval window with autogenous tissue (vein, fascia) to prevent perilymph fistula.
Do not subject to
microwave radiation
Yes
Yes
NONE
Intended for Use in MRI
Environment Biocompatible
WARNINGS
Accessories
Custom
Microwave
with osseous fragment in U-shaped hooklet of Schobel-Causse prosthesis (see detailed surgical instructions available from U.S distributor and/or manufacturer)
Not labeled
Not specified
None specified
Yes
Not labeled
Not specified
None specified
Yes
r For preservation of stapedial muscle reflex (s. also Exh. 3, pp 3+4; Exh. 6a: Stapedius Tendon Reconstruction During Stapedotomy: Techniques and Results and Exh. 6b: Preservation of the Stapedius Tendon in Laser Stapes Surgery, Laryngoscope 108; Oct. 1998)
8
Distinctive Features of KURZ Socket Stapes Pistons w/o Loop (Schobel + Schobel-Causse)
-
Pistons articulate with incus process. No loop required for fastening prosthesis on incudal 1. process.
Blood circulation in delicate periosteum is not inhibited; therefore, necrosis due to pressure at incudal process may be avoided with high degree of certainty. -
- Easy Placement: Positioning between fascia-covered oval window and incudal process under slight tension.
- No cutting or implant manipulation;
- 0.25 mm lenoth increments assure exact fitting;
- Substitution of stapedial annular ligament drastically reduces perilymphatic fistula formation.
-
Special hook for easy connection of stapedius tendon. in primary surgery (Schobel-Causse) 3. Maintenance of stapedius reflex function.
-
- Excellent biocompatibility of titanium material.
-
ട്. No special instruments.
8/19/1999
9
Image /page/9/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 6 1999
Heinz Kurz GmbH Medizintechnik c/o Dagmar S. Maeser Business Support International Amstel 320-I 1017 AP Amsterdam The Netherlands
Re: K992839 Trade Name: Socket Stapes Piston w/o Loop (Schobel) + (Schobel-Causse) Regulatory Class: II Product Code: 77 ETB Dated: August 18, 1999 Received: August 23, 1999
Dear Mr. Maeser:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations .
10
Image /page/10/Figure/0 description: The image shows the text "Page 2 – Mr. Dagmar S. Maeser". The text is in a serif font and is black. The text is centered on the page. The words "Page 2" are separated from the rest of the text by a dash.
This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in a classification for your devices and thus, permits your devices to proceed to the market.
If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801 and additionally 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 devices, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its tollfree number (800) 638-2041 or at (301) 443-6597.
Sincerely yours,
Alvey L. Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
11
Heinz Kurz GmbH Medizintechnik
510(k) - 77 ETB
| 510(k) Number | K992839 |
|---|---|
| Device Names | 1 Socket Stapes Piston w/o Loop (Schobel) |
| 2 Socket Stapes Piston w/o Loop (Schobel-Causse) | |
| Classification | Prosthesis, Partial Ossicular Replacement |
| Product Code | 77 ETB Class II 21 CFR 874.3450 |
INDICATIONS FOR USE
| Otosclerosis Surgery: | Replacement of the stapes after stapedotomy
and stapedectomy. |
|-----------------------|------------------------------------------------------------------|
| SCHOBEL: | Initial and secondary surgery |
| SCHOBEL-CAUSSE: | Initial surgery with retention of stapedial muscle
reflex. |
The stapes prostheses and custom accessories are exclusively intended for use by qualified medical personnel trained in middle ear reconstructive surgery.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use V
(Per CFR 801 109)
(Division Sign-Off)
Division of Ophthalmic Devic...
OR
510(k) Number K992839
Over-The-Counter Use
(Optional Format 1-2-96)