DORO Sterile Disposable Skull Pins Stainless Steel, Adult (36 pcs) (3006-00); DORO Sterile Disposable Skull Pins Stainless Steel, Pediatric (36 pcs) (3006-10); DORO Sterile Disposable Skull Pin Titanium, Adult (36 pcs) (3006-20); DORO Sterile Disposable Skull Pin Titanium, Pediatric (36 pcs) (3006-30); DORO Sterile Disposable Skull Pin Stainless Steel, Adult (36 pcs) (3006-50)

Q: Who is the manufacturer of DORO Sterile Disposable Skull Pins Stainless Steel, Adult (36 pcs) (3006-00); DORO Sterile Disposable Skull Pins Stainless Steel, Pediatric (36 pcs) (3006-10); DORO Sterile Disposable Skull Pin Titanium, Adult (36 pcs) (3006-20); DORO Sterile Disposable Skull Pin Titanium, Pediatric (36 pcs) (3006-30); DORO Sterile Disposable Skull Pin Stainless Steel, Adult (36 pcs) (3006-50)?

Pro Med Instruments GmbH filed the 510(k) submission for DORO Sterile Disposable Skull Pins Stainless Steel, Adult (36 pcs) (3006-00); DORO Sterile Disposable Skull Pins Stainless Steel, Pediatric (36 pcs) (3006-10); DORO Sterile Disposable Skull Pin Titanium, Adult (36 pcs) (3006-20); DORO Sterile Disposable Skull Pin Titanium, Pediatric (36 pcs) (3006-30); DORO Sterile Disposable Skull Pin Stainless Steel, Adult (36 pcs) (3006-50) (K241883).

Q: What is the FDA product code for DORO Sterile Disposable Skull Pins Stainless Steel, Adult (36 pcs) (3006-00); DORO Sterile Disposable Skull Pins Stainless Steel, Pediatric (36 pcs) (3006-10); DORO Sterile Disposable Skull Pin Titanium, Adult (36 pcs) (3006-20); DORO Sterile Disposable Skull Pin Titanium, Pediatric (36 pcs) (3006-30); DORO Sterile Disposable Skull Pin Stainless Steel, Adult (36 pcs) (3006-50)?

HBL. It is classified under 21 CFR 882.4460 as a Class 2 device in the Neurology panel.

Q: What is the regulatory pathway for DORO Sterile Disposable Skull Pins Stainless Steel, Adult (36 pcs) (3006-00); DORO Sterile Disposable Skull Pins Stainless Steel, Pediatric (36 pcs) (3006-10); DORO Sterile Disposable Skull Pin Titanium, Adult (36 pcs) (3006-20); DORO Sterile Disposable Skull Pin Titanium, Pediatric (36 pcs) (3006-30); DORO Sterile Disposable Skull Pin Stainless Steel, Adult (36 pcs) (3006-50)?

510(k) clearance (submission type: Special).

Q: What are the predicate devices for DORO Sterile Disposable Skull Pins Stainless Steel, Adult (36 pcs) (3006-00); DORO Sterile Disposable Skull Pins Stainless Steel, Pediatric (36 pcs) (3006-10); DORO Sterile Disposable Skull Pin Titanium, Adult (36 pcs) (3006-20); DORO Sterile Disposable Skull Pin Titanium, Pediatric (36 pcs) (3006-30); DORO Sterile Disposable Skull Pin Stainless Steel, Adult (36 pcs) (3006-50)?

DORO Sterile Disposable Skull Pins (K193438).

Q: Who can help prepare an FDA 510(k) submission like DORO Sterile Disposable Skull Pins Stainless Steel, Adult (36 pcs) (3006-00); DORO Sterile Disposable Skull Pins Stainless Steel, Pediatric (36 pcs) (3006-10); DORO Sterile Disposable Skull Pin Titanium, Adult (36 pcs) (3006-20); DORO Sterile Disposable Skull Pin Titanium, Pediatric (36 pcs) (3006-30); DORO Sterile Disposable Skull Pin Stainless Steel, Adult (36 pcs) (3006-50)?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K241883 · Pro Med Instruments GmbH · HBL · Jul 26, 2024 · Neurology

Device Facts

Record ID	K241883
Device Name	DORO Sterile Disposable Skull Pins Stainless Steel, Adult (36 pcs) (3006-00); DORO Sterile Disposable Skull Pins Stainless Steel, Pediatric (36 pcs) (3006-10); DORO Sterile Disposable Skull Pin Titanium, Adult (36 pcs) (3006-20); DORO Sterile Disposable Skull Pin Titanium, Pediatric (36 pcs) (3006-30); DORO Sterile Disposable Skull Pin Stainless Steel, Adult (36 pcs) (3006-50)
Applicant	Pro Med Instruments GmbH
Product Code	HBL · Neurology
Decision Date	Jul 26, 2024
Decision	SESE
Submission Type	Special
Regulation	21 CFR 882.4460
Device Class	Class 2
Attributes	Pediatric

Intended Use

The DORO Sterile Disposable Skull Pin is utilized in a skull clamp and is applied to the patient's skull to hold their head and neck securely in a particular position when rigid fixation is desired. The skull clamp is indicated for use in open and percutaneous craniotomies as well as spinal surgery when rigid fixation is necessary.

Device Story

DORO Sterile Disposable Skull Pins are single-use, sterile, disposable devices designed for rigid cranial fixation during neurosurgical procedures. The device consists of a metal pin insert (Stainless Steel or Titanium) with an injection-molded polymer collet. Three pins are installed into a DORO skull clamp to stabilize the patient's head and neck. The Titanium version is intended for use during intra-operative X-ray, CT, or MR imaging. The device is operated by neurosurgeons in clinical settings. The pins provide mechanical stability to the skull, allowing for precise surgical access. The color-coded collets assist the user in differentiating between adult/pediatric sizes and MR-conditional/MR-unsafe status. The device is supplied sterile via gamma irradiation.

Clinical Evidence

Bench testing only. Testing included axial load and creep tests, shear tests, packaging performance, interface testing with skull clamps, biocompatibility (cytotoxicity and chemical analysis), color coding verification, and sterility validation (VDmax). Titanium pins were verified as MR-conditional.

Technological Characteristics

Materials: Stainless Steel 1.4034 or Titanium Grade 5 (Ti-6Al-4V) with ABS polymer base. Sensing/Actuation: Mechanical rigid fixation. Dimensions: Adult (0.21" tip diameter) and Pediatric (0.18" tip diameter). Connectivity: None. Sterilization: Gamma irradiation. Form factor: Disposable pin with collet.

Indications for Use

Indicated for use in combination with a skull clamp in open and percutaneous craniotomies as well as spinal surgery when rigid fixation is necessary.

Regulatory Classification

Identification

A neurosurgical head holder (skull clamp) is a device used to clamp the patient's skull to hold head and neck in a particular position during surgical procedures.

Predicate Devices

DORO Sterile Disposable Skull Pins (K193438)

Related Devices

K193438 — DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium) · Pro Med Instruments GmbH · Jun 2, 2020
K071458 — MAYFIELD RADIOLUCENT DISPOSABLE SKULL PINS · Integra LifeSciences Corporation · Jun 13, 2007
K122225 — STERILE RADIOLUCENT SKULL PINS · Brainlab AG · Apr 26, 2013
K072208 — MAYFIELD DISPOSABLE AND REUSABLE TITANIUM SKULL PINS · Integra LifeSciences Corporation · Sep 7, 2007
K053045 — MODIFICATION TO: MAYFIELD RADIOLUCENT SKULL PINS, MODEL 4-0-A-2020 · Integra LifeSciences Corporation · Nov 21, 2005

Submission Summary (Full Text)

{0} FDA U.S. FOOD & DRUG ADMINISTRATION July 26, 2024 pro med instruments GmbH Anja Krumm Associate Regulatory Affairs Manager Boetzinger Strasse 86 Freiburg, Baden-Württemberg 79111 Germany Re: K241883 Trade/Device Name: DORO Sterile Disposable Skull Pins Stainless Steel, Adult (36 pcs) (3006-00); DORO Sterile Disposable Skull Pins Stainless Steel, Pediatric (36 pcs) (3006-10); DORO Sterile Disposable Skull Pin Titanium, Adult (36 pcs) (3006-20); DORO Sterile Disposable Skull Pin Titanium, Pediatric (36 pcs) (3006-30); DORO Sterile Disposable Skull Pin Stainless Steel, Adult (36 pcs) (3006-50) Regulation Number: 21 CFR 882.4460 Regulation Name: Neurosurgical Head Holder (Skull Clamp) Regulatory Class: Class II Product Code: HBL Dated: June 28, 2024 Received: June 28, 2024 Dear Anja Krumm: 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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.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. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K241883 - Anja Krumm Page 2 Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Adam D. Pierce -S Digitally signed by Adam D. Pierce -S Date: 2024.07.26 13:01:42 -04'00' Adam D. Pierce, Ph.D. Assistant Director {2} K241883 - Anja Krumm Page 3 DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3} FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF | DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. | | --- | --- | | 510(k) Number (if known) K241883 | | | Device Name DORO® Sterile Disposable Skull Pins Stainless Steel, Adult (3006-00); DORO® Sterile Disposable Skull Pins Stainless Steel, Pediatric (3006-10); DORO® Sterile Disposable Skull Pin Titanium, Adult (3006-20); DORO® Sterile Disposable Skull Pin Titanium, Pediatric (3006-30); DORO® Sterile Disposable Skull Pin Stainless Steel, Adult (3006-50) | | | Indications for Use (Describe) Indicated for use in combination with a skull clamp in open and percutaneous craniotomies as well as spinal surgery when rigid fixation is necessary. | | | Type of Use (Select one or both, as applicable) ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | | | CONTINUE ON A SEPARATE PAGE IF NEEDED. | | | This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* | | | The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov | | | "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." | | {4} K241883 Page 1 of 9 SUBMISSION NUMBER: K241883 DATE: 07/26/2024 APPLICANT: pro med instruments GmbH Bötzinger Straße 86 79111 Freiburg im Breisgau Germany Tel: +49 (0) 761 384 222 10 Fax: +49 (0) 761 384 222 81 E-Mail: info@blackforestmedical.com CONTACT PERSON: Name: Anja Krumm Position: Associate Regulatory Affairs Specialist Tel.: +49 (0) 761 384 222 781 E-Mail: regulatoryaffairs@blackforestmedical.com {5} K241883 Page 2 of 9 # 1 Device Name Trade Name: DORO Sterile Disposable Skull Pins Skull Common Name: Pins Device Classification Name: Holder, Head, Neurosurgical (Skull Clamp) # 2 Classification / Product Code DORO Sterile Disposable Skull Pins can be classified according to following device name and product code: | Device | Regulation Description | Regulation Medical Specialty | Review Panel | Product Code | Regulation Number | Device Classification | | --- | --- | --- | --- | --- | --- | --- | | Holder, head, neurosurgical (skull clamp) | Neurosurgical head holder (skull clamp) | Neurology | Neurology | HBL | 882.4460 | 2 | # 3 Predicate Device / Reference Device Subject Device 1: DORO Sterile Disposable Skull Pins (Stainless Steel) | Subject Device | Predicate Device | 510(k) Number | 510(k) Holder | | --- | --- | --- | --- | | DORO® Sterile Disposable Skull Pins (Stainless Steel) | DORO® Sterile Disposable Skull Pins | K193438 | pro med instruments GmbH | | Model: 3006-00 Stainless Steel, Adult, blue 3006-10 Stainless Steel, Pediatric, yellow 3006-50 Stainless Steel, Adult, black | | | | Subject Device 2: DORO Sterile Disposable Skull Pins (Titanium) | Subject Device | Predicate Device | 510(k) Number | 510(k) Holder | | --- | --- | --- | --- | | DORO® Sterile Disposable Skull Pins (Titanium) | DORO® Sterile Disposable Skull Pins | K193438 | pro med instruments GmbH | | Model: 3006-20 Titanium, Adult, orange 3006-30 Titanium, Pediatric, green | | | | {6} K241883 Page 3 of 9 # 4 Device Description DORO Sterile Disposable Skull Pins are disposable devices. These are delivered sterile (gamma-sterilization), ready for use, and are intended to be disposed after one use. DORO Sterile Disposable Skull Pins are available in 2 different types (Stainless Steel & Titanium) and 2 different sizes (Adult & Pediatric). # 4.1 DORO Sterile Disposable Skull Pins (Stainless Steel) DORO Sterile Disposable Skull Pins (Stainless Steel) are used together with the DORO® Headrest Systems, intended as a neck and head support to stabilize the patient's head during neurosurgical procedures. Two DORO Sterile Disposable Skull Pins are inserted into the rocker arm side of the skull clamp and one single skull pin is inserted in the opposite side. # 4.2 DORO Sterile Disposable Skull Pins (Titanium) DORO Sterile Disposable Skull Pins are used together with the DORO Headrest System, intended as a neck and head support to stabilize the patient's head during neurosurgical procedures. Two DORO Sterile Disposable Skull Pins are inserted into the rocker arm side of the skull clamp and one skull pin is inserted in the opposite side. DORO Sterile Disposable Skull Pins (Titanium) are used when Intra-Operative X-Ray-, CT- or MR-Imaging of the patient is used. # 5 Intended Use The DORO Sterile Disposable Skull Pin is utilized in a skull clamp and is applied to the patient's skull to hold their head and neck securely in a particular position when rigid fixation is desired. The skull clamp is indicated for use in open and percutaneous craniotomies as well as spinal surgery when rigid fixation is necessary. {7} K241883 Page 4 of 9 # 6 Technological Characteristics The technological characteristics of DORO® Sterile Disposable Skull Pins are the same as the technological characteristics of the predicate device. ## 6.1 DORO Sterile Disposable Skull Pins (Stainless Steel) | | pro med instruments GmbH --- DORO Sterile Disposable Skull Pins (Stainless Steel) (Subject Device) | | pro med instruments GmbH --- DORO Sterile Disposable Skull Pins (Stainless Steel) (K193438) | | | --- | --- | --- | --- | --- | | Device Name | DORO Sterile Disposable Skull Pins (Stainless Steel) | | DORO Sterile Disposable Skull Pins (Stainless Steel) | | | Regulation Number | 882.4460 | | 882.4460 | | | Class | 2 | | 2 | | | Code | HBL | | HBL | | | 510(k) number | --- | | K193438 | | | Intended Use | The DORO Sterile Disposable Skull Pin is utilized in a skull clamp and is applied to the patient's skull to hold their head and neck securely in a particular position when rigid fixation is desired. The skull clamp is indicated for use in open and percutaneous craniotomies as well as spinal surgery when rigid fixation is necessary. | | The DORO Sterile Disposable Skull Pin is utilized in a skull clamp and is applied to the patient's skull to hold their head and neck securely in a particular position when rigid fixation is desired. The skull clamp is indicated for use in open and percutaneous craniotomies as well as spinal surgery when rigid fixation is necessary. | | | Indication for use | Indicated for use in combination with a skull clamp in open and percutaneous craniotomies as well as spinal surgery when rigid fixation is necessary. | | Indicated for use in combination with a skull clamp in open and percutaneous craniotomies as well as spinal surgery when rigid fixation is necessary. | | | Material | Stainless Steel 1.4034 with a polymer base ABS | | Stainless Steel 1.4034 with a polymer base PA6 | | | Size | Adult Pediatric | | Adult Pediatric | | | Tip Cone Angle | Adult: 35° Pediatric: 43° | | Adult: 35° Pediatric: 43° | | | Tip Diameter | Adult: 0.21 Inches Pediatric: 0.18 Inches | | Adult: 0.21 Inches Pediatric: 0.18 Inches | | | mounting shaft diameter | Adult: 0.31 inches Pediatric: 0.31 inches | | Adult: 0.31 inches Pediatric: 0.31 inches | | | O-Ring | 3006-00 Stainless Steel, Adult, Blue | No O-Ring | 3006-00 Stainless Steel, Adult, Blue | No O-Ring | | | 3006-10 Stainless Steel, Pediatric, Yellow | No O-Ring | 3006-10 Stainless Steel, Pediatric, Yellow | No O-Ring | | | 3006-50 Stainless Steel, Adult, Black | O-Ring | 3006-50 Stainless Steel, Adult, Black | O-Ring | {8} K241883 Page 5 of 9 | | pro med instruments GmbH --- DORO® Sterile Disposable Skull Pins (Stainless Steel) (Subject Device) | | pro med instruments GmbH --- DORO® Sterile Disposable Skull Pins (Stainless Steel) (K193438) | | | --- | --- | --- | --- | --- | | Manufacturing | 3006-00 Stainless Steel, Adult, Blue 3006-10 Stainless Steel, Pediatric, Yellow | The pin insert is machined according to the dimensions specified and cleaned afterwards. The Pin collet is injection-molded around the Pin insert in controlled environmental conditions. | 3006-00 Stainless Steel, Adult, Blue 3006-10 Stainless Steel, Pediatric, Yellow | The pin insert is machined according to the dimensions specified and cleaned afterwards. The Pin collet is injection-molded around the Pin insert in controlled environmental conditions. | | | 3006-50 Stainless Steel, Adult, Black | The pin insert is machined according to the dimensions specified and cleaned afterwards. Assembly of the O-Ring takes place in controlled environmental condition. | 3006-50 Stainless Steel, Adult, Black | The pin insert is machined according to the dimensions specified and cleaned afterwards. Assembly of the O-Ring takes place in controlled environmental condition. | | Preparation for surgery | None, the pins are supplied sterile in a 3-pack blister ready for use | | None, the pins are supplied sterile in a 3-pack blister ready for use | | | Method of Use | Typically, three pins are installed in receptacles of the head holder | | Typically, three pins are installed in receptacles of the head holder | | | Clamp Compatibility | DORO Sterile Disposable Skull Pins are compatible with all the models of DORO brand skull clamps. | | DORO Sterile Disposable Skull Pins are compatible with all the models of DORO brand skull clamps. | | | MR Compatibility | MR Unsafe | | MR Unsafe | | | Method of Sterilization | Gamma Irradiation | | Gamma Irradiation | | | Use | Disposable; Single-Patient Use only | | Disposable; Single-Patient Use only | | | Packaging | Medical grade packaging (sealed TYVEK/Blister) | | Medical grade packaging (sealed TYVEK/Blister) | | {9} K241883 Page 6 of 9 # 6.2 DORO Sterile Disposable Skull Pins (Titanium) | | pro med instruments GmbH --- DORO Sterile Disposable Skull Pins (Titanium) (Subject Device) | | pro med instruments GmbH --- DORO Sterile Disposable Skull Pins (Titanium) (K193438) | | | --- | --- | --- | --- | --- | | Device Name | DORO Sterile Disposable Skull Pins (Titanium) | | DORO Sterile Disposable Skull Pins (Titanium) | | | Regulation Number | 882.4460 | | 882.4460 | | | Class | 2 | | 2 | | | Code | HBL | | HBL | | | 510(k) number | --- | | K193438 | | | Intended Use | The DORO Sterile Disposable Skull Pin is utilized in a skull clamp and is applied to the patient's skull to hold their head and neck securely in a particular position when rigid fixation is desired. The skull clamp is indicated for use in open and percutaneous craniotomies as well as spinal surgery when rigid fixation is necessary. | | The DORO Sterile Disposable Skull Pin is utilized in a skull clamp and is applied to the patient's skull to hold their head and neck securely in a particular position when rigid fixation is desired. The skull clamp is indicated for use in open and percutaneous craniotomies as well as spinal surgery when rigid fixation is necessary. | | | Indication for use | Indicated for use in combination with a skull clamp in open and percutaneous craniotomies as well as spinal surgery when rigid fixation is necessary. | | Indicated for use in combination with a skull clamp in open and percutaneous craniotomies as well as spinal surgery when rigid fixation is necessary. | | | Material | Titanium Grade 5 (Ti-6AI-4V) with a polymer base ABS | | Titanium Grade 5 (Ti-6AI-4V) with a polymer base PA6 | | | Size | Adult Pediatric | | Adult Pediatric | | | Tip Cone Angle | Adult: 35° Pediatric: 43° | | Adult: 35° Pediatric: 43° | | | Tip Diameter | Adult: 0.21 Inches Pediatric: 0.18 Inches | | Adult: 0.21 Inches Pediatric: 0.18 Inches | | | mounting shaft diameter | Adult: 0.31 inches Pediatric: 0.31 inches | | Adult: 0.31 inches Pediatric: 0.31 inches | | | O-Ring | 3006-20 Titanium, Adult, Orange | No O-Ring | 3006-20 Titanium, Adult, Turquoise | No O-Ring | | | 3006-30 Titanium, Pediatric, Green | No O-Ring | 3006-30 Titanium, Pediatric, Green | No O-Ring | {10} K241883 Page 7 of 9 | | pro med instruments GmbH --- DORO Sterile Disposable Skull Pins (Titanium) (Subject Device) | | pro med instruments GmbH --- DORO Sterile Disposable Skull Pins (Titanium) (K193438) | | | --- | --- | --- | --- | --- | | Manufacturing | 3006-20 Titanium, Adult, Orange 3006-30 Titanium, Pediatric, Green | The pin insert is machined according to the dimensions specified and cleaned afterwards. The Pin collet is injection-molded around the Pin insert in controlled environmental conditions. | 3006-20 Titanium, Adult, Turquoise 3006-30 Titanium, Pediatric, Green | The pin insert is machined according to the dimensions specified and cleaned afterwards. The Pin collet is injection-molded around the Pin insert in controlled environmental conditions. | | Preparation for surgery | None, the pins are supplied sterile in a 3-pack blister ready for use. | | None, the pins are supplied sterile in a 3-pack blister ready for use. | | | Method of Use | Typically, three pins are installed in receptacles of the head holder. | | Typically, three pins are installed in receptacles of the head holder. | | | Clamp Compatibility | DORO® Sterile Disposable Skull Pins are compatible with all the models of Doro brand skull clamps. | | DORO® Sterile Disposable Skull Pins are compatible with all the models of Doro brand skull clamps. | | | MR Compatibility | MR Conditional Main magnetic field strength: 1.5 Tesla or 3 Tesla SAR: Up to first level control mode (4 W/kg) | | MR Conditional Main magnetic field strength: 1.5 Tesla or 3 Tesla SAR: Up to first level control mode (4 W/kg) | | | Method of Sterilization | Gamma Irradiation | | Gamma Irradiation | | | Use | Disposable; Single-Patient Use only | | Disposable; Single-Patient Use only | | | Packaging | Medical grade packaging (sealed TYVEK/Blister) | | Medical grade packaging (sealed TYVEK/Blister) | | ## 6.3 Summary of Technological Characteristics DORO Sterile Disposable Skull Pins (Stainless Steel & Titanium) are substantially equivalent in intended use, indication for use, dimensions and design to the predicate devices. Therefore, safety and effectiveness can be ensured for these items. {11} K241883 Page 8 of 9 # 7 Performance Data The DORO Sterile Disposable Skull Pins (Stainless steel & Titanium) have been tested as a system and single device. Tests were performed and the results are shown in the table below. | Test | Result | | --- | --- | | DORO Sterile Disposable Skull Pins (Stainless Steel & Titanium) | | | Axial Load and Creep Test Confirms the ability of the skull pins to withstand typical loads w/ additional safety factor utilizing the worst-case product. | Pass The Pins are able to withstand typical static loads w/ additional safety factor w/o plastic deformation and an accepted distension. | | Shear Test Confirms the ability of the skull pins and its interface with the cranial bone to withstand typical shear force w/ additional safety factor utilizing the worst-case product. | Pass The Pins are able to withstand typical shear force w/ additional safety factor w/o spatial locomotion. | | Packaging System Performance and Stability Confirms the capability of the transport packing as well as the of product packaging to protect the skull pins against hazards, which may occur during handling, storage, and transport by air or ground. Confirms the capability of the sterile barrier system of the blister pack as well as the blister pack itself utilized for the skull pins whether it is effective, efficient and safe to use. | Pass The utilized packing system for the skull pins is capable to protect those against visible damage. The utilized sterile barrier system as well as the blister pack was proven to perform efficiently, safely, and effectively. | | Interface Test Confirms safe and effective utilization of the skull pins w/ skull clamps w/o negative impact on utilized single-use gloves | Pass Skull Pins performer safely and effectively. | | Biological Evaluation Confirms the biocompatibility of the skull pins by cytotoxicity test and chemical analysis of utilized materials. | Pass The skull pins obtain no cell growth inhibiting character. No chemical substance above harmful threshold was detected. | | Color Coding Confirms the coloring of the plastic pin collets that enables the user to differentiate between MR conditional and MR unsafe skull pins as well as between skull pins for the adult population and pediatric population. | Pass Differentiation between designated patient populations as well as different applications is possible due to different colors utilized for the plastic pin collets. | | Sterility Test Confirms the sterility of the skull pins as well as the maintained sterility of the skull pins at the end of the product's shelf life. | Pass VDmax validation as well as dye penetration test have proven the sterility of the product at delivery status as well as at the end of shelf life. | {12} K241883 Page 9 of 9 | Test | Result | | --- | --- | | DORO Sterile Disposable Skull Pins (Titanium) | | | MR-Safety Verifies the MR- Compatibility of the skull pins dedicated for the utilization in conjunction with MRT scanner utilizing the worst-case product. | Pass The skull pins are MR conditional. | Testing confirmed that the performance of the DORO® Sterile Disposable Skull Pins meets the product specification of the device. # 8 Substantial Equivalence Summary / Conclusion DORO Sterile Disposable Skull Pins (Stainless Steel & Titanium) are used together with the DORO Headrest System, intended as a neck and head support to stabilize the patient's head during neurosurgical procedures. These devices are comparable in design, construction, intended use and performance characteristics to the predicate device K193438. Based on available 510(k) information herein provided, DORO® Sterile Disposable Skull Pins are considered substantially equivalent to the predicate device K193438 in terms of intended use, technology and performance specifications. There are no differences between the devices which may raise new issues concerning safety or effectiveness.