(76 days)
Not Found
Not Found
No
The summary describes a battery-operated drill with a skull perforator, and explicitly states it does not assist the surgeon during the procedure. There are no mentions of AI, ML, image processing, or data sets typically associated with AI/ML devices.
No
The device aids in a surgical procedure by perforating the skull, but it does not treat or cure a disease or condition itself. It's a surgical tool, not a therapeutic agent.
No
The device is a battery-operated drill intended to aid surgeons in perforating the skull, which is an interventional/surgical tool rather than a diagnostic one. It does not provide any information or analysis about the patient's condition.
No
The device description explicitly states it is a "battery operated drill that has a skull perforator permanently attached to it," indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states the device is a battery-operated drill with a skull perforator used to physically perforate the skull. It is a surgical tool used on the patient's body, not for analyzing specimens from the body.
- Intended Use: The intended use is to aid the surgeon in a surgical procedure (perforating the skull), not to provide diagnostic information based on analysis of biological samples.
Therefore, the ACRA-CUT XPRESS 120 is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
"This device is for use on the skull area only. This device is disposable and for single patient use only. The device is used to aid the surgeon in perforating the skull for various types of purposes. The device does not the surgeon in perforating the skull foe variot assist the surgeon during the procedure. Decisions about what to do and how to perform a procedure rest firmly with the surgeon."
Product codes (comma separated list FDA assigned to the subject device)
HBF
Device Description
"The ACRA-CUT XPRESS 120 is a battery operated drill that has a skull perforator permanently attached to it. It is for one time use and is delivered charged and sterile."
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skull area
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)
"No clinicals were performed with this device."
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.
Not Found
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
DEC = 8 2003
03297o
510-k Summary
Pursuant to 21 CFR 807.93 the following summary is submitted.
- Submitter's name-ACRA-CUT, Inc. 989 Main Street Acton, MA 01720 1-978-263-0250 Contact Person-Kenneth M. Nicoll (603) 672-3161
-
- Proprietary Name = XPRESS 120 Common Name = Surgical Drill and Perforator
-
We are claiming substantial equivalence to the Osteomed B Power System and the Stryker System II Orthopower 90 Battery Powered Instruments.
-
The ACRA-CUT XPRESS 120 is a battery operated drill that has a skull perforator permanently attached to it. It is for one time use and is delivered charged and sterile.
XPRESS 120 is very similar in how the battery-operated drill operates, is used and in technological characteristics to the Osteomed B Power System and the Stryker System II Orthopower 90 Battery Powered Instruments, except as to where on the body the drill will be used. The XPRESS 120 is intended to be used only in the skull area, while the substantially equivalent products are intended to be used on other parts of the human body, including the skull in the case of the Osteomed product. The XPRESS 120 is also substantially equivalent to the ACRA-CUT perforators already approved, as the submission relates to the perforators themselves. The perforators are identical except that now they are permanently attached to the drill.
-
The ACRA-CUT XPRESS 120 is for use on the skull area only. The device is disposable and for single use only. The device is used to aid the surgeon in perforating the skull for various types of purposes.
-
No clinicals were performed with this device.
1
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing the bird's body and wings. The bird is facing left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
DEC - 8 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
ACRA-CUT, Inc. c/o Mr. Kenneth M. Nicoll Regulatory Consultant 74 Spring Road Amherst, New Hampshire 03031
Re: K032970
Trade/Device Name: XPRESS 120 Regulation Number: 21 CFR 882.4305 Regulation Name: Powered compound cranial drills, burrs, trephines and their accessories Regulatory Class: II Product Code: HBF Dated: September 5, 2003 Received: September 23, 2003
Dear Mr. Nicoll:
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. Ilisting 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.
2
Page 2 - Mr. Kenneth M. Nicoll
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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/cdrf/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
fel 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
3
Exhibit 3
INDICATIONS FOR USE
510-k Number: No K number yet, new submission. K 0329 9 J
Device Name: XPRESS 120
Indications For Use:
This device is for use on the skull area only. This device is disposable and for single patient use only. The device is used to aid the surgeon in perforating the skull for various types of purposes. The device does not the surgeon in perforating the skull for variot assist the surgeon during the procedure. Decisions about what to do and how to perform a procedure rest firmly with the surgeon.
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR Over- The-Counter-Use _________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)
( Please do not write below this line. Continue on another page if needed )
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
Page 1 of 1
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K032970