(83 days)
Not Found
No
The description focuses on a mechanical release mechanism based on bone thickness, not on data-driven learning or inference.
No.
A therapeutic device is typically involved in treating a disease or condition, reducing symptoms, or restoring function. This device is a surgical cutting accessory used to create burr-holes, which is a preparatory step for other neurological procedures, not a therapeutic action itself.
No
This device is a surgical cutting accessory used for cranial burr-hole trephination. It is used to create holes in the skull, not to diagnose a condition.
No
The device is a physical cutting accessory intended for cranial surgery, driven by a motor. It is explicitly described as a "single-use cutting accessory" and a "single-use surgical device."
Based on the provided text, the adeor® Meridian™ Cranial Perforator is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for "cranial burr-hole trephination in neurological surgery." This is a surgical procedure performed directly on a patient's body.
- Device Description: The device is described as a "single-use cutting accessory intended to perform cranial burr-hole trephination in neurosurgery." It is a mechanical tool used for drilling bone.
- Mechanism of Action: The device works by physically cutting and drilling through the skull. It has a mechanical release mechanism.
- Anatomical Site: The anatomical site is the "cranium," which is part of the patient's body.
- Performance Studies: The performance studies involve drilling holes in wood, animal bone, and animal cadavers. These are not in vitro diagnostic tests performed on biological samples outside the body.
In Vitro Diagnostic (IVD) devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. The Meridian™ Cranial Perforator does not perform any such analysis of biological samples. It is a surgical instrument used for a physical procedure.
N/A
Intended Use / Indications for Use
Intended Use: The adeor® Meridian™ Cranial Perforator is a sterile, single-use cutting accessory intended for cranial burr-hole trephination in neurological surgery
Indications for Use: The Meridian™ Perforator is a single-use surgical device for cranium perforation. The device automatically releases and stops perforating at cranial bone thickness of at least 3 mm. The Meridian™ pediatric perforator version automatically releases and stops perforating at cranial bone thickness of at least 1.5 mm.
The perforators are available in three sizes: for burr-hole diameters of 6 mm, 7 mm and 11 mm.
Pediatric: for bone thickness of at least 1.5 mm:
PER 6-9-SP
PER 7-11-SP
PER 11-14-SP
For bone thickness of at least 3.0 mm:
PER 6-9-S
PER 7-11-S
PER 11-14-S
Product codes (comma separated list FDA assigned to the subject device)
HBF
Device Description
The Meridian™ Cranial Perforator is a sterile packed, single-use cutting device intended to perform cranial burr-hole trephination in neurosurgery, driven by powered sources having a standardized and commonly used Hudson fitting clutch. The device automatically releases and stops perforating at cranial bone thickness of at least 3 mm. The Meridian™ pediatric perforators automatically release and stop perforating at cranial bone thickness of at least 1.5 mm. Both versions are available for burr-hole diameters of Prevent 6. Prevent 7 and Prevent 11 mm.
The Meridian™ Cranial Perforator per CFR. Part 882.4305, is a bone cutting and drilling instrument driven by a pneumatic or electric surgical motor in order to drill burr-holes through the skull of a patient. An integrated clutch mechanism prevents plunging of the perforator tip into the underlying dura and parenchyma tissue. The device is a Class II (USA) device and classified IIa in Europe (EEC).
The Meridian™ Cranial Perforator is a device similar in design and construction to other cranial perforators currently on the market; (e.g.: Acra-Cut models DGR-II and Codman Disposable Perforators etc ... )
The Meridian™ Cranial Perforator requires a motor and an attached or integrated speed reducer in order to run the perforators at a speed range of 800 ... 1200 RPM.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cranium / skull
Indicated Patient Age Range
The Meridian™ pediatric perforators automatically release and stop perforating at cranial bone thickness of at least 1.5 mm.
Intended User / Care Setting
neurological 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Bench Testing:
Samples of each model were used to drill holes in wood and animal bone to verify its mechanical functionality similar to predicate devices. The release mechanism worked reliable on both materials and stopped cutting as soon as the thin remaining pad of material became elastic.
On animal cadavers (pig head and calf shoulder) the release mechanism worked reliable and a clear bone pad has been formed which can easily be removed from the bur-hole. All tests have been performed satisfactory with the following positive remarks: The release mechanism worked reliable on several bur-holes. There was no friction observed between the rotating cutting parts. There has been no skidding of the subject device on the animal cadaver bone. A firm axial rotation and no wobbling of the subject device have been observed. A plain and even surface of the perforated bone and on the bone flap was observed. (See "Performance Bench testing protocol" for details in Chapter 18)
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.
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
§ 882.4305 Powered compound cranial drills, burrs, trephines, and their accessories.
(a)
Identification. Powered compound cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments used on a patient's skull. The instruments employ a clutch mechanism to disengage the tip of the instrument after penetrating the skull to prevent plunging of the tip into the brain.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the word "adeor" in a simple, sans-serif font. To the left of the word is a cluster of black dots, arranged in a pattern that resembles a stylized star or burst. The dots vary in size, with some being larger and more prominent than others.
510(k) Summarv
JUL 1 7 2012
| Submitter: | adeor Medical Technologies GmbH
Kirchpaltz 1
82049 Pullach
Germany |
|----------------------|-----------------------------------------------------------------------------|
| Contact Person: | Fabio von Zeppelin
General Manager |
| | Phone: +49 (0)89-744 42 398
Fax: +49 (0)89-744 24 809 |
| Preparation Date: | April 16th, 2012 |
| Trade Name: | Meridian™ Cranial Perforator |
| Common Name: | Cranial Perforator |
| Classification Name: | Neurological surgical devices |
Device Description:
The Meridian™ Cranial Perforator is a sterile packed, single-use cutting device intended to perform cranial burr-hole trephination in neurosurgery, driven by powered sources having a standardized and commonly used Hudson fitting clutch. The device automatically releases and stops perforating at cranial bone thickness of at least 3 mm. The Meridian™ pediatric perforators automatically release and stop perforating at cranial bone thickness of at least 1.5 mm. Both versions are available for burr-hole diameters of Ø6. Ø7 and Ø11 mm.
The Meridian™ Cranial Perforator per CFR. Part 882.4305, is a bone cutting and drilling instrument driven by a pneumatic or electric surgical motor in order to drill burr-holes through the skull of a patient. An integrated clutch mechanism prevents plunging of the perforator tip into the underlying dura and parenchyma tissue. The device is a Class II (USA) device and classified IIa in Europe (EEC).
The Meridian™ Cranial Perforator is a device similar in design and construction to other cranial perforators currently on the market; (e.g.: Acra-Cut models DGR-II and Codman Disposable Perforators etc ... )
The Meridian™ Cranial Perforator requires a motor and an attached or integrated speed reducer in order to run the perforators at a speed range of 800 ... 1200 RPM.
1
Image /page/1/Picture/0 description: The image contains a sequence of characters that appear to be handwritten. The sequence starts with the letters 'klala' followed by the numbers '253'. The characters are written in a simple, clear style, with consistent line thickness.
Image /page/1/Picture/1 description: The image shows the logo for Adeor. The logo consists of a cluster of black dots in the upper left corner, arranged in a pattern that resembles a constellation or a network. To the right of the dots is the word "adeor" in lowercase, sans-serif font. The overall design is simple and modern.
Intended Use:
The adeor® Meridian™ Cranial Perforator is a sterile, single-use cutting accessory intended for cranial burr-hole trephination in neurological surgery
Indications for Use:
The Meridian™ Perforator is a single-use surgical device for cranium perforation. The device automatically releases and stops perforating at cranial bone thickness of at least 3 mm. The Meridian™ pediatric perforator version automatically releases and stops perforating at cranial bone thickness of at least 1.5 mm.
Predicate Devices:
| K933894, K071931 | 2 | Disposable Perforators | 2 | Codman & Shurtleff, Inc. |
|---|---|---|---|---|
| K833266 | 3 | Automatic Cranial Drill | ||
| (Perforator) | 3 | Acra Cut, Inc. |
Substantial Equivalence:
The Meridian™ Cranial Perforator is substantially equivalent to the currently marketed Acra-Cut DGR-II and Codman 26-1221 based on the device's similarity to the predicate devices in indications, principle of operations, materials and design. The predicate and subject devices are marketed in the European Union as substantially equivalent.
Technological Characteristics Comparison:
| Acra-Cut Inc. | Codman | Adeor | |
|---|---|---|---|
| Parameters: | DGR-II | 26-1221 | Meridian |
| Class | II | II | II |
| Indications for Use: | The Acra-Cut DGR-I is | ||
| designed to | |||
| automatically release | |||
| and stop upon | |||
| penetration of bone that | |||
| is at least 3 mm thick. | |||
| The DGR-II perforator is | |||
| for use on thin skull/skull | |||
| areas such as pediatric, | |||
| temporal and | |||
| suboccipital areas. They | |||
| are designed to | |||
| automatically release | |||
| and stop upon | |||
| penetration of bone as | |||
| thin as 1 mm. | The Codman Disposable | ||
| Perforator is for use in | |||
| perforating the cranium. | |||
| When properly used, it is | |||
| designed to | |||
| automatically disengage | |||
| once perforation is | |||
| accomplished and when | |||
| pressure is removed | |||
| from the drill point. | The Meridian™ | ||
| Perforator is a, single-use | |||
| surgical device for | |||
| cranium perforation. The | |||
| device automatically | |||
| releases and stops | |||
| perforating at cranial | |||
| bone thickness of at | |||
| least 3 mm. | |||
| The Meridian™ pediatric | |||
| perforators automatically | |||
| release and stop | |||
| perforating at cranial | |||
| bone thickness of at | |||
| least 1.5 mm. | |||
| Dimensions and design: | similar | similar | similar |
| Materials | Plastic/ stainless steel | Plastic/stainless steel | Plastic/stainless steel |
| Fitting | Hudson | Hudson | Hudson |
| Principle of operation | similar | similar | similar |
| Cutting Performance | similar | similar | similar |
05_510(k)_Summary rev. 01.doc
Page 2 of 4
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Image /page/2/Picture/1 description: The image shows the logo for Adeor. The logo consists of a cluster of dots in the upper left corner, arranged in a pattern that resembles a stylized star or burst. To the right of the dots is the word "adeor" in lowercase letters. The font is simple and sans-serif, and the overall design is clean and modern.
| Burr hole diameters Ø | Ø 5/8,7/11,11/14 mm | Ø 6/9, 7/11, 11/14 mm | Ø 6/9, 7/11, 11/14 mm |
|---|---|---|---|
| Release mechanism | automatic | automatic | automatic |
| Rotation speed | 800 RPM | Not-known | 800-1200 RPM |
| Cutting performance | similar | similar | similar |
| Single-use supply | Gamma sterile | Gamma sterile | Gamma sterile |
The technological characteristics of the subject device are based on the same cranial perforator technology as the predicate devices. Substantial equivalence of the Meridian™ Adeor cranial perforator is based upon the comparison to predicate device's characteristics.
Performance Standards:
Performance standards have not been established by the FDA under Section 514 of the Federal Food, Drug and Cosmetic Act.
Performance testing:
Substantial equivalence of the Meridian™ Adeor cranial perforator is based upon the comparison to predicate device's technical characteristics, indications, principle of operations, materials, design, and sterile supply as a single-use medical device.
Performance Bench Testing:
Samples of each model were used to drill holes in wood and animal bone to verify its mechanical functionality similar to predicate devices. The release mechanism worked reliable on both materials and stopped cutting as soon as the thin remaining pad of material became elastic.
On animal cadavers (pig head and calf shoulder) the release mechanism worked reliable and a clear bone pad has been formed which can easily be removed from the bur-hole. All tests have been performed satisfactory with the following positive remarks: The release mechanism worked reliable on several bur-holes. There was no friction observed between the rotating cutting parts. There has been no skidding of the subject device on the animal cadaver bone. A firm axial rotation and no wobbling of the subject device have been observed. A plain and even surface of the perforated bone and on the bone flap was observed. (See "Performance Bench testing protocol" for details in Chapter 18)
Sterilzation Process Validation:
The sterilization process is based on international Standards ISO 11137-1:2006, ISO 11137-2:2006 and ISO 11137-3:2006 which are recognized by FDA, as well.
The sterilization dose of 25 kGy has been validated according to ISO 11137-1:2006, ISO 11137-2:2006 (see Validation Report: Radiation Sterilization for product family "Perforators" n. PR/7-5-0-331). Latest revalidation has been performed 05-24-2012.
The sterilization process according to standards ISO 11137-1:2006, ISO 11137-2:2006 and ISO 11137-3:2006 has been validated (see Validation Report: Radiation Sterilization "HiCut & Perforators" n. V 7-5-0-235 R).
3
Image /page/3/Picture/0 description: The image shows a handwritten string of characters. The string appears to be a combination of a letter and numbers. The string reads 'K121253'.
Image /page/3/Picture/1 description: The image shows the word "adeor" in lowercase letters. To the left of the word is a cluster of black dots that are arranged in a circular pattern. The dots vary in size, with the largest dots in the center and the smallest dots on the periphery.
The Test Report no. 100239-10 (see annex) investigation indicates that any microbial contamination of the device (average bioburden of three independent lots 25 kGy ensures a SAL