(24 days)
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.
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.
The provided document is a 510(k) summary for a medical device (stapes prostheses) and does not contain the detailed study information needed to fully address all aspects of the request. However, based on the available information, here's a breakdown of what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are primarily based on demonstrating substantial equivalence to predicate devices rather than specific quantitative performance metrics. The document asserts that the device compares favorably and shows at least equal, if not better improvement of all hearing parameters compared to predicate devices. It also highlights design features intended to improve safety and effectiveness.
| Acceptance Criteria (Inferred from 510(k) Submission) | Reported Device Performance (as stated in the document) |
|---|---|
| Intended Use Equivalence: Same intended use as predicate devices (replacement of stapes after stapedotomy or stapedectomy in otosclerosis surgery). | The KURZ stapes prostheses have the same intended use as predicate devices. |
| Material Biocompatibility: Material used is biocompatible. | ASTM F67 medical grade titanium has a proven record of excellent biocompatibility. |
| Design Safety/Effectiveness: Design differences do not adversely affect safety and effectiveness; ideally, enhance them. | "The different material (titanium) 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." |
| Fixation Stability: Stable fixation to the incus. | "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)." |
| Prevention of Complications: Reduced risk of perilymphatic fistula or necrosis. | "Drastic Reduction of Perilymphatic Fistula or Necrosis Formation" and "Substitution of Stapedial Annular Ligament drastically reduces perilymphatic fistula formation." |
| Hearing Improvement: Comparable or improved hearing parameters. | "At least equal, if not better improvement of all hearing parameters can be achieved when compared to SE devices." |
| MRI Compatibility: Safe in MRI environment. | "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." |
| Manufacturing/Compliance: Compliance with relevant industry standards for manufacturing, packaging, labeling, and sterilization. | KURZ certifies compliance with required ISO/EN/ASTM/AAM//ANSI and other device-related standards. |
2. Sample size used for the test set and the data provenance
The document refers to "Clinical results to date," "Intermediate Report on clinical investigation on titanium middle-ear implants in comparison to other materials," and "Long-Term Clinical Results" since 1979 for the Schobel socket piston. However, specific sample sizes for a dedicated test set are not provided. The provenance of the data is generally clinical (implants in patients) but the country of origin is not explicitly stated, although the manufacturer is German. It appears to be retrospective data analysis ("Since 1979 the Schobel socket piston... has been implanted").
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The "ground truth" for the clinical results would implicitly be the observed patient outcomes and surgeon assessments.
4. Adjudication method for the test set
This information is not provided in the document.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC study was mentioned or implied. This device is a surgical implant, not an AI-driven diagnostic tool that would typically involve human "readers" in the context of interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth appears to be based on clinical outcomes data ("excellent hearing improvement," "not a single case of incus necrosis, loosening of articulation with lenticular processus, or membrane penetration into the vestibulum," and general statements about "audio results achieved" and "hearing parameters"). For MRI compatibility, the ground truth was derived from testing in a nuclear magnetic resonance tomograph.
8. The sample size for the training set
The concept of a "training set" in the context of device validation for this type of implant (pre-2000 510(k) submission) is not applicable in the same way as it would be for an AI/ML device. The "training" here refers to cumulative clinical experience with the device and similar concepts. The "Long-Term Clinical Results" state that the Schobel socket piston "Since 1979... has been implanted," implying a substantial number of cases over two decades, but an exact numerical "training set" size is not given.
9. How the ground truth for the training set was established
As above, the "training set" is not a formal concept here. The "ground truth" for the long-term clinical results was established through patient follow-up and observation of clinical outcomes after implantation by surgeons. The document cites "Prof. H. Schobel, On Development of New Stapes Prosthesis in Otosclerosis Surgery" in relation to these results, suggesting clinical studies and expert observation.
{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 | tkurz@kurzmed.deusteinhardt@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 OssicularReplacement |
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 11/11/9Company of Children1 | and of the status of the county of the last------------------------------------------------------------------------------------------------------------------------------------------------------------------------------VAIIF | CHIT'NEDUCW |
|---|---|---|---|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
{5}------------------------------------------------
| KURZ | XOMED | SMITH & NEPHEW | |
|---|---|---|---|
| Device | Socket Stapes Pistonw/o Loop | 1. Causse TEF-Pistons2. RobinsonStapedectomy3. Cupped Pistons | 1. Fluoroplastic Pistons2. Cup Pistons3. Lippy Modified - Stainless4. Richards Bucket Handle5. Shea Cup6. Shea Platinum/Fluoroplastic |
| Model(s) | 1. Schobel 100650x2. Schobel-Causse 100651x | 1. PTFE Polymer 11-563xxTeflon 11-290xx2. Teflon XO-24xx3. Stainless St. 11-33xxx11-564xx | 1. Fluoroplastic 14-0xxx2. Stainless 14-2xxx3. Stainless 14-211x4. Stainless 14-20xx5. Fluoroplastic 14-21xxFluoropl. L/R 14-04xxFluoroplastic w/Platinum Loop 14-06xx |
| IntendedUse | Otosclerosis Surgery:Replacement of Stapesafter Stapedectomy andStapedotomy | Otosclerosis Surgery:Replacement of Stapesafter Stapedectomy andStapedotomy | Otosclerosis Surgery:Replacement of Stapesafter Stapedectomy |
| Schobel | initial & secondary surgery | ||
| Schobel-Causse | initial; designed to receivestapedius tendon to retainstapedial muscle reflex | Causse TEF Pistons:Retention of stapedialtendon | |
| Material | ASTM F67 Medical GradeTitanium | PTFE PolymerTeflonStainless Steel | Fluoroplastic, Stainless Steel,Fluoroplastic with Platinum Loop |
| Contra-Indications | Known titanium allergy +general preoperativeconsiderations, i.e.:- acute & chronicinfections- general woundhealing disorders- alcohol, drugs, andnicotine abuse | Not known | 1. When more conservative treat-ment will suffice;2. When infection is present aslater scarring could causedisplacement of prosthesis;3. Stapedectomy in better or only-hearing ear not advisable due torisk of cochlear deafness. |
| AdverseEffects +InteractionsMRIX-ray +ComputedTomographyMicrowave | • Harmless;• The image quality maybe impeded nearimplant• Piston can be preciselylocalized• DO NOT EXPOSE(s. WARNINGS below) | Not known | Complications include:1. Postoperative sensorineuraldeafness due to surgicaltrauma and reparative granuloma and perilymph fistula;2. Labyrinthitis;3. Vertigo;4. Incus necrosis;5. Tympanic membrane perfor6. Otitis media;7. Prosthesis displacement;8. Recurrence of oval windowfixation. |
| Single UseDevice | YES | YES | YES |
| ProvidedSterile | YES | YES | YES |
| SterilizationMethod | Gamma Irradiation | Not known | Ethylene Oxide |
2 13 ... COMPARISON WITH PREDICATE DEVICES
{6}------------------------------------------------
COMPARISON WITH PREDICATE DEVICES 2.13 .
| KURZ | XOMED | SMITH + NEPHEW | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ResterilizationPermitted | NO | Not known | YES - ETO, Autoclaving (250-254 F) and Flash Steam Autoclaving(270-274° F) depending on implant material | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
| DesignComparisonDescription | Titanium piston ( $\varnothing$ 0.4mm) with socket-like top for articulation to lenticularincus 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. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
| DesignComparisonIllustration(Not shown atsame 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Weight5SchobelSchobel-Causse | 3.5 mg4.0 mg | Not labeled | Not labeled; known example:Fluoplastic-PlatinumLength 5 mm - $\varnothing$ 6 mm =5 mg | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
| HandlingPrecautions | 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 | |
|---|---|---|---|
| Substitutionof StapedialAnnularLigament6 | YES | YES - with Causse-TEF | YES |
| Retention ofStapediusTendon7 | YES - Only with Schobel-Causse Model inprimary surgery | YES - with Causse-TEF | NO |
| SurgicalProcedure | Enaural, Endomeatal orRetroauricular:- Atticotomy to exposeossicular chain;- Determine prosthesislength prior tointerrupting chain;Caution: Piston may notproject more than 0.5mm into vestibule!- Cut incudostapedial jointwithout damagingincudal process;- Cut dorsal stapedial crusjust above and belowstapedius tendonattachment;- Keep flap of vein orfascia in standbyposition;- With laser or diamonddrill cut 0.8 mm Ø holein footplate;- Close immediately withvein or fascia;- While slightly liftingincudal process, placeprosthesis on membraneand connect socket toincudal process. | Causse TEF0.8mm hole is drilled in thirdposterior of footplate. Largevein graft interposition is usedto discourage piston shaft frompressing upon saccule in caseof vacuum in middle ear.Gently crimping the loop helpssecure it around incus. Seal ismade with small pieces ofperivenous tissue to secureposition.Cupped Piston DesignSelf-centering prostheseseliminate need for wirecrimping 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 stapedotomyand stapedectomy. |
|---|---|
| SCHOBEL: | Initial and secondary surgery |
| SCHOBEL-CAUSSE: | Initial surgery with retention of stapedial musclereflex. |
The stapes prostheses and custom accessories are exclusively intended for use by qualified medical personnel trained in middle ear reconstructive surgery.
(PLEASE DO NOT WRITE BELOW THIS LINE ~ CONTINUE ON ANOTHER PAGE IF NEEDED)
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)
§ 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.