(174 days)
Not Found
No
The description focuses on the device being a manual surgical instrument made of standard materials, with no mention of AI/ML, image processing, or data-driven features.
No.
The device is described as a specialized manual surgical instrument for retraction during spinal surgery, and its intended use as a retractor does not make it a therapeutic device that directly treats or cures a disease.
No
The device is described as a "specialized manual surgical instrument" intended for providing "access to the thoracic and lumbar spinal column during minimally invasive and endoscopic surgical provides a selflocking type surgical retraction system." Its function is mechanical retraction during surgery, not diagnosing conditions or measuring physiological parameters.
No
The device description explicitly states it is a manual instrument made from stainless steel, PEEK, or titanium, indicating it is a physical hardware device, 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 it's a "specialized manual surgical instrument" used for "providing access to the thoracic and lumbar spinal column during minimally invasive and endoscopic surgical." This describes a surgical tool used on the body during a procedure, not a device used to test samples from the body (which is the definition of an IVD).
- Device Description: The description confirms it's a "reusable manual instrument made from stainless steel, PEEK or titanium." This aligns with a surgical instrument, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests, or providing diagnostic information based on laboratory analysis.
Therefore, this device falls under the category of a surgical instrument, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The device intended for use as a specialized manual surgical instrument. It is reusable and intended to provide access to the thoracic and lumbar spinal column during minimally invasive and endoscopic surgical provides a selflocking type surgical retraction system with inflatable tissue protectors.
Product codes (comma separated list FDA assigned to the subject device)
GZT
Device Description
GEISTER Medizintechnik GmbH Self-retaining Retractors are reusable manual instruments made from stainless steel, PEEK or titanium. They are sold unsterile and can be re-processed according the instructions for use.
Microdiscectomy Retractors: Ring handle retractors consist of two conioined shanks held via a spring loaded ratchet. Distraction is performed by pressing the ring handles together until the anatomical structures are distracted sufficiently. Ring handle retractors are available in different styles with fixed shanks and fixed blades. As well there are types with hinqed shanks and exchangeable blades in different length and width configurations to adapt it to different patient anatomy.
SpineControl Cervical Retractor System: Frame type retractors consist of a toothed frame with one fixed shank and one moveable shank. The movable shank can be distracted via a pinion action with a wing screw or a turning knob to adjust it to the opening of the wound. It is self-retaining via a spring loaded ratchet lever and can be released by pressing this ratchet lever. Blades are exchangeable and available in different length and width configurations to adapt it to a wide range of patient anatomy. The shanks can be hinged to optimize the adjustment to the surgical site.
Self-Retaining Retractors: Frame type & ring handle retractors. Blades are exchangeable in different length and width configurations to adapt it to a wide range of patient anatomy. The shanks can be hinged to optimize the adjustment to the surgical site.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic and lumbar spinal column
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)
The following testing done to show safety and effectiveness of our system:
- . Biocompatibility
- Re-processing and sterilization ●
- . Performance testing bench
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.
K003740, K964402, K060097, K913233
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
§ 882.4800 Self-retaining retractor for neurosurgery.
(a)
Identification. A self-retaining retractor for neurosurgery is a self-locking device used to hold the edges of a wound open during neurosurgery.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 29, 2018
Geister Medizintechnik GmbH Christian Grotzinger Quality Manager Forhenstrasse 2 Tuttlingen, 78532 De
Re: K180610
Trade/Device Name: Geister retractor for neuro - and spine surgery Regulation Number: 21 CFR 882.4800 Regulation Name: Self-Retaining Retractor For Neurosurgery Regulatory Class: Class II Product Code: GZT Dated: July 2, 2018 Received: July 9, 2018
Dear Christian Grotzinger:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/ofdocs/ofpmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803). please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerelv.
Jennifer R. Stevenson -S3
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K180610
Device Name
Geister® Retractor for neuro- and spine surgery
Type of Use (Select one or both, as applicable)
Indications for Use (Describe)
The device intended for use as a specialized manual surgical instrument. It is reusable and intended to provide access to the thoracic and lumbar spinal column during minimally invasive and endoscopic surgical provides a selflocking type surgical retraction system with inflatable tissue protectors.
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ---------------------------------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------------- |
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K180610
VOLUME 006
510(k) Summary
DATE OF APPLICATION: 2018-08-28
Geister Medizintechnik GmbH APPLICANT: Föhrenstrasse 2 78532 Tuttlingen Germany Tel.: +49 7461 96624 0 Fax: +49 7461 96624 22
CONTACT PERSON: Christian Grötzinger Quality Manager (Director) Tel.: +49 7461 96624 109 Fax: +49 7461 96624 22
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1. Device Name
1.1. Retractor
Trade Names: Geister® retractor for neuro - and spine surgery Regulation description: Self-retaining retractor for neurosurgery
2. Classification Product Code / Subsequent Code
2.1. Retractor
| Device | Medical
Specialty | Review Panel | Product Code | Device Class | Requlation
Number |
|------------------------------------------------------|----------------------|--------------|--------------|--------------|----------------------|
| Retractor, Self-
retaining, For Neuro-
surgery | Part 882 | Neurology | GZT | 2 | 882.4800 |
Predicate Device 3.
Geister Retractor are equivalent to the following predicate devices, most recently cleared by the FDA:
| Geister Product | Primary Predicate Device | 510(k) Number | 510(k) Holder |
|---|---|---|---|
| Geister® retractor for neuro – and | |||
| spine suregery | miaspas® miniTTA | K003740 | Aesculap |
| Predicate Devices | 510(k) Number | ||
| Versatrac™ lumbar retractor system | K964402 | ||
| Grossman self-retaining low profile brain retractor | K060097 | ||
| Codman Ihalo split ring retractor system | K913233 | Codman |
4. Description of the Device
4.1. Self-retaining retractor for neurosurgery
| Dimensions retractor | 65mm to 542mm |
|---|---|
| Dimensions blades | 10mm to 180mm |
| Materials | Titanium (3.7165 - TiAl6 V4), Stainless Steel (1.4021 - X20Cr13 & 1.4305 - X12CrNiS18-8) & |
| PEEK black | |
| Coatings | Black coated, blue & green anodized |
| Retractor system /groups | Microdiscectomy Retractors, SpineControl Cervical Retractor System & Self-Retaining Retractors |
5. Indications for Use
The device intended for use as a specialized manual surgical instrument. It is reusable and intended to provide access to the thoracic and lumbar spinal column during minimally invasive and endoscopic surgical procedures. Provides a self-locking type surgical retraction system.
Device description 6.
GEISTER Medizintechnik GmbH Self-retaining Retractors are reusable manual instruments made from stainless steel, PEEK or titanium. They are sold unsterile and can be re-processed according the instructions for use.
Microdiscectomy Retractors 6.1.
Ring handle retractors consist of two conioined shanks held via a spring loaded ratchet. Distraction is performed by pressing the ring handles together until the anatomical structures are distracted sufficiently. Ring handle retractors are available in different styles with fixed shanks and fixed blades. As well there are
5
Image /page/5/Picture/1 description: The image shows the word "GEISTER" in a bold, sans-serif font. The word is slightly curved, and there is a faint, circular shape behind it. The registered trademark symbol is visible to the right of the word.
types with hinqed shanks and exchangeable blades in different length and width configurations to adapt it to different patient anatomy.
6.2. SpineControl Cervical Retractor System
Frame type retractors consist of a toothed frame with one fixed shank and one moveable shank. The movable shank can be distracted via a pinion action with a wing screw or a turning knob to adjust it to the opening of the wound. It is self-retaining via a spring loaded ratchet lever and can be released by pressing this ratchet lever. Blades are exchangeable and available in different length and width configurations to adapt it to a wide range of patient anatomy. The shanks can be hinged to optimize the adjustment to the surgical site.
Self-Retaining Retractors 6.3.
Frame type & ring handle retractors. Blades are exchangeable in different length and width configurations to adapt it to a wide range of patient anatomy. The shanks can be hinged to optimize the adjustment to the surgical site.
7. Testing
The following testing done to show safety and effectiveness of our system:
- . Biocompatibility
- Re-processing and sterilization ●
- . Performance testing bench
Substantial Equivalence Summary / Conclusion 8.
Based on available 510(k) information provided herein, GEISTER's retractor for neuro - and spine surgery is considered substantial equivalent to the predicate devices in terms of indications for use, material, technology, design and performance specifications. There are no differences between the devices which would raise new issues of safety or effectiveness.