(426 days)
Insurgical™ Single Use Power Equipment is intended for use in the cutting, drilling, decorticating, and smoothing of bone and other bone related tissue in a variety of surgical procedures. It is also usable in the placement or cutting of screws, wires, pins, and other fixation devices. It can also be used to cut metal.
The Insurgical™ Single Use Power Equipment System includes surgical power tools and rechargeable batteries. The battery powered DC Motor products include the Insurgical Drill, and the Insurgical Orthopedic Reamer. Insurgical handpieces and attachments are provided pre-sterilized and ready to use. The powered DC Motor products and attachments are single-use and intended to be disposed of after use. The batteries can be recharged and are re-usable. The Insurgical Drill is designed for drilling holes and placing bone screws in a variety of reconstructive and trauma procedures. The Insurgical Orthopedic Reamer can be used for boring, drilling, and reaming during orthopedic procedures.
The provided text is a 510(k) Summary for the Insurgical™ Single Use Power Equipment. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and detailed performance metrics as one might find for a novel AI/software medical device.
Therefore, the requested information elements related to AI/software performance studies (such as sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth types) are not applicable to this submission. The "acceptance criteria" here refer to the successful completion of various engineering and safety tests to show the device is safe and effective and similar to a predicate.
Here's an attempt to answer the questions based on the provided text, acknowledging the differences in scope:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Test Performed) | Reported Device Performance/Outcome |
|---|---|
| IEC 60601-1-2 (Electromagnetic Compatibility) | Successful outcome to establish device safety and equivalence. |
| CISPR 11 (Electromagnetic Disturbance) | Successful outcome to establish device safety and equivalence. |
| IEC 61000-4-2 (Electrostatic Discharge Immunity) | Successful outcome to establish device safety and equivalence. |
| IEC 61000-4-3 (Radiated RF Immunity) | Successful outcome to establish device safety and equivalence. |
| Cadaveric simulated use test | Successful outcome to establish device safety and equivalence. (This test likely evaluated the device's functional performance in a simulated surgical environment.) |
| Laboratory validation of aseptic battery transfer process | Successful outcome to establish device safety and equivalence. (This test likely confirmed that the non-sterile battery could be transferred aseptically to the sterile handpiece, maintaining sterility of the surgical field.) |
| UL1642 (Safety for Lithium Batteries) | Successful outcome to establish device safety and equivalence. |
| ISO 10993-5 (Cytotoxicity) | Successful outcome to establish device safety and equivalence. (This test ensures that materials in contact with the patient do not cause toxic effects.) |
2. Sample sized used for the test set and the data provenance
The document does not specify sample sizes for any of these tests. For most of the engineering and safety standards (IEC, CISPR, UL, ISO), the "sample size" is typically determined by the standard itself (e.g., testing a certain number of units or cycles to demonstrate compliance). For the cadaveric simulated use test, a specific number of cadavers or test runs is not mentioned. Data provenance is not explicitly stated, but it would typically be from internal laboratory testing conducted by the manufacturer or a certified testing facility.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a hardware device submission focused on safety and equivalence, not a diagnostic or AI device requiring expert-established ground truth for a test set.
4. Adjudication method for the test set
Not applicable. This is a hardware device submission.
5. 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 hardware device submission, not an AI or software-assisted diagnostic.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a hardware device submission.
7. The type of ground truth used
For the engineering and safety tests, the "ground truth" is compliance with the specific requirements and limits defined by each standard (e.g., passing electromagnetic immunity tests, showing no cytotoxicity). For the cadaveric simulated use test, the "ground truth" would be the successful and safe performance of the intended surgical actions without mechanical failure or other safety concerns.
8. The sample size for the training set
Not applicable. This is a hardware device submission, not an AI/machine learning device that uses a training set.
9. How the ground truth for the training set was established
Not applicable. This is a hardware device submission.
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K 1125.99 Page lot 3
NOV
6 200
510(k) Summary Pursuant to 21 CFR 807.92
Date of preparation: November 5, 2012
- Insurgical, LLC Submitted By: 1. 9600 Great Hills Trail, Suite 150W Austin, Texas 78759
- David C. Furr 2. Contact: FDC Services, LLC 8708 Capehart Cove Austin, Texas 78733 512-906-9654
- Insurgical™ Single Use Power Equipment Product: 3. Unclassified Product Code: KIJ
-
- Common/Trade Name:
Instrument, Surgical, Orthopedic, DC Powered Motor and Accessory/Attachment
Insurgical™ Single Use Power Equipment
Description:
The Insurgical™ Single Use Power Equipment System includes surgical power tools and rechargeable batteries. The battery powered DC Motor products include the Insurgical Drill, and the Insurgical Orthopedic Reamer.
Insurgical handpieces and attachments are provided pre-sterilized and ready to use. The powered DC Motor products and attachments are single-use and intended to be disposed of after use. The batteries can be recharged and are re-usable. The Insurgical Drill is designed for drilling holes and placing bone screws in a variety of reconstructive and trauma procedures. The Insurgical Orthopedic Reamer can be used for boring, drilling, and reaming during orthopedic procedures.
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K112599 Page 2 of 3
Intended Use:
Insurgical TM Single Use Power Equipment is intended for use in the cutting, drilling, decorticating, and smoothing of bone and other bone related tissue in a variety of surgical procedures. It is also usable in the placement or cutting of screws, wires, pins, and other fixation devices. It can also be used to cut metal.
Testing and Technological Characteristics:
The Insurgical™ Single Use Power Equipment System includes DC powered components with accessories. The devices are hand-held and provided sterile. They are for single use orthopedic surgical applications.
The handpieces include a trigger lock, which can be engaged to safely allow for attachment of accessories. The devices are powered by DC batteries, which are non-sterile and reusable.
The following testing was conducted with successful outcome to establish device safety and equivalence:
- IEC 60601-1-2 Medical Electrical Equipment/Part 1: General . Requirements for Safety - Collateral Standard: Electromagnetic Compatibility
- CISPR 11 Industrial, scientific and medical (ISM) radio frequency . equipment - Electromagnetic disturbance characteristics - Limits and methods of measurement
- IEC 61000-4-2 Electromagnetic Compatibility Part 4: Testing and . Measurement Techniques Section 2: Electrostatic Discharge Immunity Test
- IEC 61000-4-3 Electromagnetic Compatibility for Electrical and . Electronic Equipment, Part 3: Immunity to Radiated, Radio Frequency, Electromagnetic Fields
- Cadaveric simulated use test .
- Laboratory validation of aseptic battery transfer process .
- UL1642 Safety for Lithium Batteries .
- ISO 10993-5 Cytotoxicity .
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K112599 Page 3 of 3
Substantial Equivalence:
The Insurgical Single Use Power Equipment is substantially equivalent to Stryker System 4000 Heavy Duty Battery Powered Equipment (K972367).
The predicate device has similar technical features, indications for use, and the safety and effectiveness of the devices is equivalent.
Conclusions:
The predicate device and the Insurgical Single Use Power Equipment share similar indications, technology, and application. The Insurgical product is equivalent to the predicate device products in key areas of performance that affect safety and effectiveness.
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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure embracing or protecting another figure, representing the department's mission of protecting the health of all Americans.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
Insurgical, LLC % FDC Services, LLC Mr. David C. Furr Principal Consultant 8708 Capehart Cove Austin, Texas 78733
November 6, 2012
Re: K112599
Trade/Device Name: Insurgical™ Single Use Power Equipment Regulatory Class: Unclassified Product Code: KIJ Dated: October 03, 2012 Received: October 10, 2012
Dear Mr. Furr:
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.
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Page 2 – Mr. David C. Furr
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 (240) 276-0115. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Peter D. Rumm -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Premarket Notification Insurgical Single Use Power Equipment
Page 1 of 1:
Indications for Use Statement
510(k) Number:
Device Name:
Insurgical™ Single Use Power Equipment
Indications for Use:
Insurgical™ Single Use Power Equipment is intended for use in the cutting, drilling, decorticating, and smoothing of bone and other bone related tissue in a variety of surgical procedures. It is also usable in the placement or cutting of screws, wires, pins, and other fixation devices. It can also be used to cut metal.
Prescription Use X Over-the-counter use Or (per CFR 801.109)
Concurrence of CDRH
(Digital Sign Off)
(Division Sign On) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K112595
§ 878.4820 Surgical instrument motors and accessories/attachments.
(a)
Identification. Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.