Geister retractor for neuro - and spine surgery

K180610 · Geister Medizin Technik GmbH · GZT · Aug 29, 2018 · Neurology

Device Facts

• Record ID: K180610
• Device Name: Geister retractor for neuro - and spine surgery
• Applicant: Geister Medizin Technik GmbH
• Product Code: GZT · Neurology
• Decision Date: Aug 29, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4800
• Device Class: Class 2

Intended 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 with inflatable tissue protectors.

Device Story

Reusable manual surgical instrument system; provides access to thoracic and lumbar spinal column during minimally invasive and endoscopic procedures. System includes ring handle retractors with spring-loaded ratchets and frame-type retractors with pinion-action shanks; features exchangeable blades and hinged shanks to accommodate patient anatomy. Used in clinical surgical settings by surgeons. Device provides self-locking retraction to maintain surgical site exposure; benefits patient by facilitating minimally invasive access. Sold unsterile; requires reprocessing by healthcare facility.

Clinical Evidence

Bench testing only. Evidence includes biocompatibility, re-processing/sterilization validation, and performance testing.

Technological Characteristics

Materials: Titanium (3.7165 - TiAl6 V4), Stainless Steel (1.4021 - X20Cr13 & 1.4305 - X12CrNiS18-8), and PEEK black. Coatings: Black, blue, and green anodized. Dimensions: Retractor 65mm-542mm; Blades 10mm-180mm. Mechanism: Manual, spring-loaded ratchet or pinion-action with wing screw/turning knob. Form factor: Ring handle or frame-type retractors. Sterilization: Reusable, requires facility reprocessing.

Indications for Use

Indicated for patients undergoing minimally invasive or endoscopic thoracic and lumbar spinal column surgery requiring surgical retraction.

Regulatory Classification

Identification

A self-retaining retractor for neurosurgery is a self-locking device used to hold the edges of a wound open during neurosurgery.

Predicate Devices

• miaspas® miniTTA (K003740)
• Versatrac™ lumbar retractor system (K964402)
• Grossman self-retaining low profile brain retractor (K060097)
• Codman Ihalo split ring retractor system (K913233)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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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.

| <div> <span> <span style="font-size: 12px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |
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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.: [phone] Fax: [phone]

> E-Mail: [e-mail] www.geister.com

CONTACT PERSON: Christian Grötzinger Quality Manager (Director) Tel.: [phone] Fax: [phone]

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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<br>Specialty | Review Panel | Product Code | Device Class | Requlation<br>Number |
|------------------------------------------------------|----------------------|--------------|--------------|--------------|----------------------|
| Retractor, Self-<br>retaining, For Neuro-<br>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<br>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) &<br>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

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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.