(76 days)
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 assist the surgeon during the procedure. Decisions about what to do and how to perform a procedure rest firmly with the surgeon.
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.
This device, the ACRA-CUT XPRESS 120, is a surgical drill and perforator. Based on the provided 510(k) summary, it is being submitted for substantial equivalence to existing predicate devices.
Here's an analysis regarding acceptance criteria and supporting studies:
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A table of acceptance criteria and the reported device performance
Acceptance Criteria Reported Device Performance Substantial Equivalence: The XPRESS 120 should be substantially equivalent to legally marketed predicate devices in terms of intended use, technological characteristics, and safety and effectiveness. The device is claimed to be substantially equivalent to the Osteomed B Power System and the Stryker System II Orthopower 90 Battery Powered Instruments. It is also substantially equivalent to previously approved ACRA-CUT perforators. The key difference is the specified use area (skull only for XPRESS 120) and the permanent attachment of the perforator to the drill. Intended Use: For use on the skull area only, disposable, single-patient use, to aid the surgeon in perforating the skull for various purposes. The device's stated indications for use are "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." This directly matches the acceptance criteria for its intended use. The 510(k) decision confirms that the FDA reviewed these indications for use and found substantial equivalence. Technological Characteristics: Similar in how the battery-operated drill operates, is used, and in technological characteristics to predicate devices. (Specifically, battery-operated drill with permanently attached skull perforator, delivered charged and sterile, single-use.) The XPRESS 120 is described as 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." It is explicitly stated that it is "very similar in how the battery-operated drill operates, is used and in technological characteristics" to the predicate devices. The primary difference noted is the area of the body treated. The perforators themselves are identical to already approved ACRA-CUT perforators, just now permanently attached. Safety & Effectiveness: The device must be deemed safe and effective for its intended use and equivalent to predicate devices. The FDA's substantial equivalence determination implies that the device is considered safe and effective for its intended use, given its similarity to legally marketed predicate devices that are also considered safe and effective. No specific performance metrics (e.g., drilling speed, torque, battery life) are provided, as the basis for acceptance is substantial equivalence to existing devices. -
Sample size used for the test set and the data provenance
No clinical studies or test sets with human or animal subjects were conducted for this device. The submission explicitly states: "No clinicals were performed with this device." The acceptance is based on demonstrating substantial equivalence to predicate devices already on the market. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no test set or clinical studies were performed. The "ground truth" for acceptance is based on the regulatory review of substantial equivalence to predicate devices, which involves regulatory experts at the FDA. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no test set or clinical studies were performed that would require adjudication. -
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a surgical instrument, not an AI-assisted diagnostic or imaging device. No MRMC studies were conducted. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a standalone physical surgical instrument used by a surgeon. Its performance is inherent to its design and manufacturing, and its safety/effectiveness is established through comparison to similar existing devices, not through algorithmic performance. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the device's acceptance is its substantial equivalence to legally marketed predicate devices. This doesn't involve clinical outcomes, pathology, or expert consensus on a study dataset for this specific device. Instead, it relies on the established safety and effectiveness of the existing predicate devices (Osteomed B Power System, Stryker System II Orthopower 90 Battery Powered Instruments, and existing ACRA-CUT perforators). -
The sample size for the training set
Not applicable, as no training set was used. This is a physical medical device, not an AI/ML model. -
How the ground truth for the training set was established
Not applicable, as no training set was used.
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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
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- Proprietary Name = XPRESS 120 Common Name = Surgical Drill and Perforator
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We are claiming substantial equivalence to the Osteomed B Power System and the Stryker System II Orthopower 90 Battery Powered Instruments.
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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.
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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.
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No clinicals were performed with this device.
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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.
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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
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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
§ 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).