(48 days)
No
The description focuses on mechanical operation (rotational cutting blade, trigger mechanism) and power sources (pneumatic, electric). There is no mention of AI, ML, image processing, or data-driven decision making.
No.
The Anspach PKS is described as an accessory attachment designed for cutting, shaping, and removing bone, rather than treating a disease or condition. Its function is surgical preparation or modification, not therapeutic intervention in itself.
No
The device description states its purpose is for "cutting, shaping and removal of bone," which are therapeutic or surgical actions, not diagnostic ones.
No
The device description explicitly lists hardware components (Pistol Grip Trigger Assembly housing, Straight Nose-Tube Attachment, Shielded Attachments, Cutters) and describes a physical mechanism for removing bone using a high-speed rotational cutting blade. This is clearly a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "cutting, shaping and removal of bone, including bones of the skull and spine." This is a surgical procedure performed directly on the patient's body.
- Device Description: The description details a powered surgical tool with a cutting blade for bone removal. This aligns with a surgical instrument, not a device used to examine specimens outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are used to examine specimens obtained from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The Anspach Powered Kerrison System does not fit this description.
N/A
Intended Use / Indications for Use
The Anspach Powered Kerrison System" (PKS) is indicated for use as an accessory attachment for I he rulisplay of the systems for cutting, shaping and removal of bone, including bones of the skull and spine.
Product codes (comma separated list FDA assigned to the subject device)
HAD
Device Description
The Anspach PKS is designed to be operated by either pneumatic or electric power but without the forceful, rapid forward stroke of a stationary blade in other powered rongeur systems. The Anspach PKS removes bone using a high speed rotational (85k max. rpm) cutting blade advanced by an operator controlled trigger mechanism.
PKS consists of four basic component parts:
- Pistol Grip Trigger Assembly housing
- Straight Nose-Tube Attachment
- Shielded Attachments
- Cutters
PKS is constructed of the same materials that are used in construction of other Anspach motors, nosepiece attachments and cutters. There are no new or unusual materials used in construction of any of the system's component parts. System components that contact human tissues are constructed of materials recognized as safe for their intended uses, contact and duration.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skull and spine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon
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)
Not Found
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.
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
§ 882.4845 Powered rongeur.
(a)
Identification. A powered rongeur is a powered instrument used for cutting or biting bone during surgery involving the skull or spinal column.(b)
Classification. Class II (performance standards).
0
1/2
510(k) SUMMARY: - Anspach Powered Kerrison System (PKS) Exhibit 07:
BACKGROUND:
Spine surgeons gain access to the posterior aspect of the spinal cord and its nerve roots by removing a portion of the vertebra called the laminectomy). The procedure is typically performed by using a manual "Kerrison" rongeur, powered rongeur or by some highly skilled surgeons using a high-speed drill (HSD) system with a long-straight or craniotome nosepiece attachment and burr (Anspach or similar). Powered, manual rongeurs and craniotome attachments have a footplate that is inserted between the bone of the lamina and the underlying nerve. The footplate helps to guide the blade and helps protect surrounding tissues. Once the footplate is under the surgeon squeezes the handle of the rongeur which advances the instrument's blade, bringing the cutting surface down to the footplate, biting off a small piece of the lamina.
DESIGN, MATERIALS AND OPERATION CHARACTERISTICS:
Design: The Anspach PKS is designed to be operated by either pneumatic or electric power but without the forceful, rapid forward stroke of a stationary blade in other powered rongeur systems. The Anspach PKS removes bone using a high speed rotational (85k max. rpm) cutting blade advanced by an operator controlled trigger mechanism.
PKS consists of four basic component parts:
- Pistol Grip Trigger Assembly housing મુ
- 彩 Straight Nose-Tube Attachment
-
- Shielded Attachments
-
- Cutters
Materials: PKS is constructed of the same materials that are used in construction of other Anspach motors, nosepiece attachments and cutters. There are no new or unusual materials used in construction of any of the system's component parts. System components that contact human tissues are constructed of materials recognized as safe for their intended uses, contact and duration.
Operation Characteristics: Surgeon simply removes the previous cutting burr and attachment being used and reassembles the motor with PKS in a quick, simple four-step process
- 01 Select and attach desired PKS straight nose-tube attachment to motor.
- 02 Insert through straight nose-tube attachment and lock the desired cutter.
- 03 Insert motor/nose-tube/cutter assembly through trigger housing assembly and lock into place.
- 04 Insert nose-tube/cutter assembly through burr-guard attachment and locked onto trigger assembly housing.
PKS is now assembled and ready to use. Note: Cutter tip is not extended and is in its retracted position inside straight nose-tube attachment. Surgeon places footplate of PKS burr guard between lamina and nerve (or other soft tissue or structure) and by gripping pistol-grip handle firmly, lightly squeezing the trigger to advance high-speed burr to the bone, which is quickly and effectively cut away. Releasing the trigger causes the high-speed burr to be retracted back into the straight nose-tube attachment, which can then be repositioned and the procedure repeated.
1
INDICATIONS / CONTRAINDICATIONS:
Anspach PKS is indicated for cutting and shaping bone, including bones of the skull and spine. There are currently no, known specific contraindications with use of the device.
CLEANING/STERILIZATION/MAINTENANCE:
PKS cutters are single-use, disposable and cleaning, reprocessing and re-use are not recommended. Anspach cannot guarantee maximum cutter effectiveness after its use and/or 3rd party re-processors. To ensure maximum bone cutting performance, use of a new, previously unused cutter is strongly recommended for each patient/procedure.
The PKS Pistol-Grip Handle and straight nosepiece attachments are not designed to be immersed into any liquids during cleaning (Damage to high-speed bearings could result). Manual cleaning with mild soap and water is recommended with internal cleaning accomplished by an accessory cleaning brush (available from Anspach).
Sterilization of PKS is the same as with other Anspach motor and attachment system due to the similarity in materials, design complexity and materials. Recommended Sterilization is by Steam Autoclaye at the following processing parameters: NOTE: Cleaning, sterilization and storage conditions are specified on product package inserts available with every PKS component and within a variety of surgical equipment manuals.
| Steam Autoclave/Gravity Air Displacement | 270+/- 2° (F) [132 +/-1°(C)] for 20 minutes unwrapped |
|---|---|
| Steam Autoclave/High Speed vacuum | 270+/- 2° (F) [132 +/-1°(C)] for 10 minutes wrapped or |
| 8 minutes unwrapped |
WARNINGS:
Generic Warnings for use of Anspach Motor Systems, Attachments and Cutters are specified on product inserts and equipment manuals.
For safe and effective use of any Anspach product, it is strongly suggested that specialized training be undertaken since surgical techniques using Anspach products are highly specialized and complex procedures. Improper surgical technique or improper use of Anspach products can cause severe injury or death to a user or patient and cause severe damage to Anspach products and/or other manufacturer's or user facility's equipment.
CAUTIONS:
Generic cautions for use of Anspach Motor Systems, Attachments and Cutters are specified on product inserts and equipment manuals (See Section 14 and associated exhibits).
SUBSTANTIAL EQUIVALENCE:
The Anspach PKS is a rongeur, powered by a pneumatic (air/gas) or an electric motor currently manufactured and distributed by Anspach (K831756 - Black Max; K965080 - MicroMax and; K011444 - eMax). Anspach PKS is similar in appearance, materials and has the same intended uses as other powered rongeurs and the same intended uses as both powered and manual rongeurs. The
2
foot-piece of the PKS shielded attachment is identical in materials and design to the foot-piece of other Anspach shielded attachments (K974025).
Principle difference between Anspach PKS and other rongeurs is that PKS uses a high-speed motor driven rotating burr to dissect bone instead of the straight, rigid blade system of other rongeurs. Difference between Anspach PKS and surgical techniques employing high-speed drill (HSD) systems is that PKS provides a long attachment (greater surgeon visibility) with an integral shielding feature identical to other Anspach Shielded Attachments.
| | Principle Differences Between Predicate
Devices/Methods and Anspach PKS | Powered
Rongeur | Manual
Rongeur | HSD
System | Anspach
PKS |
|----|----------------------------------------------------------------------------|--------------------|-------------------|---------------|----------------|
| 01 | US Classification | II | I | II | II |
| 02 | EU Classification | Ila | I (?) | Ila | Ila |
| 03 | Manually Powered | No | Yes | No | Yes |
| 04 | Externally powered | | | | |
| | Gas/air | Yes | No | Yes | Yes |
| | Electric | (?) | No | Yes | Yes |
| 05 | Bone Cutting Mechanism | | | | |
| | Straight, rigid blade | Yes | Yes | No | Yes |
| | High-speed rotation | No | No | Yes | Yes |
| 06 | Activation Recoil | Yes | No | No | No |
| 07 | Indicated for Skull/Spine Procedures | Yes | Yes | Yes | Yes |
| 08 | Protection of Surrounding Tissues | Yes | Yes | Yes* | Yes |
| | * When used with a shielded attachment | | | | |
| 09 | Similarity in Materials | Yes | Yes | Yes | Yes |
| | * Patient contact components | | | | |
| 10 | Indicated for Spine/Skull Procedures | Yes | Yes | Yes | Yes |
| 11 | Reusable Device | Yes | Yes | Yes | Yes* |
| | * PKS Cutters are single-use, disposable devices | | | | |
| 12 | Cutting Blade Sharpness Assurance | None | None | Yes* | Yes* |
| | * All Anspach Cutters are single-use, disposable devices | | | | |
| 13 | Cleaning Immersable | No | (?) | No | No |
| 14 | Recommended Sterilization Method | Steam | Steam | Steam | Steam |
End Summary
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure in profile, composed of three curved lines that resemble a bird in flight. The figure is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circumference of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 21 2002
The Anspach Effort, Inc. William G. Conety Director, Regulatory Affairs 4500 Riverside Drive Palm Beach Gardens, Florida 33410
Re: K022907
Trade/Device Name: Anspach Powered Kerrison System (PKS) Regulation Number: 882.4845 Regulation Name: Powered rongeur Regulatory Class: Class II Product Code: HAD Dated: August 26, 2002 Received: September 3, 2002
Dear Mr. Conety:
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. 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 (PMA), 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 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 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050,
4
Page 2 -- Mr. William G. Conety
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Muriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General. Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Number: K () 2290.7
Page 1 of 1
Device Name: "Powered Kerrison System" (PKS)
INDICATIONS FOR USE:
The Anspach Powered Kerrison System" (PKS) is indicated for use as an accessory attachment for I he rulisplay of the systems for cutting, shaping and removal of bone, including bones of the skull and spine.
DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE
Concurrence of CDRH, Office of Device Evaluation (ODE)
Muriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K022907
_ OR Over-the-Counter Usc: ___________________________________________________________________________________________________________________________________________________ Prescription Use: V_ Per 21 CFR 801.109)