(67 days)
The Hall®Smart Guard® Irrigator is an accessory to a powered instrument system consisting of drills, saws and associated handpieces to perform the cutting of soft tissue and bone. The fields of application include: orthopedic, arthroscopic, neurosurgical, otolaryngology, plastic/reconstructive and oral/maxillofacial procedures.
The proposed Hall® Smart Guard® Irrigator is also an accessory/attachment to a powered instrument system that provides irrigation at the surgical site. It is an injectionmolded, polypropylene sleeve that fits over the bur guard on the distal tip of the handpiece. A stainless steel, single-lumen tube is insert-molded into the sleeve and can be attached to irrigation tubing to direct fluid to the surgical site. Irrigation inflow is controlled by a pump integral to the console. The proposed attachments will be available as sterile, single use devices. The Hall® Smart Guard® Irrigator will be packaged in a Twek®/poly pouch.
The polypropylene contains a thermochromatic dye that changes color when the internal temperature of the bur guard reaches 135° F and before the external temperature of the Hall® Smart Guard®Irrigator reaches 122°. This feature provides a heat indicator that serves two purposes:
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- The temperature of the bur guard increases when the bearings are worn. It will alert the user that the bur guard should be serviced.
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- It will alert the user that the temperature of the Hall® Smart Guard® Irrigator has increased to the point that could result in potential patient injury.
In addition, the Hall® Smart Guard® Irrigator provides thermal insulation to the patient from heat that may be generated by the bur guard. The sleeve provides insulation to the patient by virtue of the physical barrier between the bur quard and the patient.
The provided text describes a medical device, the Hall® Smart Guard® Irrigator, and its 510(k) submission for substantial equivalence. However, it does not contain any information about acceptance criteria or a study that proves the device meets those criteria.
The document focuses on:
- Description of the device: How it works, its components, and its unique feature (thermochromatic dye for heat indication).
- Intended Use: The medical fields and procedures for which it is designed.
- Substantial Equivalence: Comparing it to legally marketed predicate devices to demonstrate it does not raise new issues of safety and efficacy.
- Regulatory Clearance: The FDA's letter granting 510(k) clearance based on substantial equivalence.
Therefore, I cannot fulfill your request for the following information as it is not present in the provided text:
- Table of acceptance criteria and reported device performance: No specific performance metrics or acceptance criteria are mentioned.
- Sample size used for the test set and data provenance: No test sets or study data are discussed.
- Number of experts used to establish ground truth and qualifications: There is no mention of expert involvement in establishing ground truth for testing.
- Adjudication method: Not applicable as no ground truth establishment is described.
- Multi-reader multi-case (MRMC) comparative effectiveness study: No such study is mentioned.
- Standalone (algorithm only) performance: Not applicable as this is a physical medical device, not an AI algorithm.
- Type of ground truth used: Not applicable as no ground truth for testing is described.
- Sample size for the training set: Not applicable as there is no training set for an AI algorithm.
- How ground truth for the training set was established: Not applicable.
The document indicates that "The changes made to the legally marketed devices have been tested to assure that the proposed modifications do not raise any new issues of safety and efficacy," but it does not provide details about these tests, their criteria, or results.
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Ko 70233
Page 182
510(k) Summary Hall® Smart Guard® Irrigator February 28, 2007
D. Predicate/Legally Marketed Devices
APR - 2 2007
The Hall® Smart Guard® Irrigator is a modification to:
| 1. Device name: | Universal Drive System |
|---|---|
| 2. Company name: | Linvatec Corporation |
| 3. 510(k) #: | K971059 |
This 510(k) also includes the modified devices cleared in Special 510(k) #s:
- K060198, MicroPower Handpiece Medium Speed Drill .
- K060260, MicroPower Handpiece High Speed Drill; and
- K060270, MicroPower Handpiece Oral Max High Speed Drill. .
E. Device Description
The descriptions of the handpiece proposed in this special 510(k) and the Universal Drive System and MicroPower Handpieces are identical. The only differences between the legally marketed handpieces and the proposed device are the design of the fluid irrigation accessory/attachment and the sterile packaging. The existing irrigation accessories consist of plastic, snap-on clips that are attached to the bur quard on the distal tip of the handpiece. A stainless steel, single-lumen tube affixed to the clip can be attached to irrigation tubing to direct fluid to the surgical site. Irrigation inflow is controlled by a pump integral to the console. These attachments are available as both sterile, single use devices and as non-sterile, re-useable devices. The sterile irrigator is packaged in a double poly/poly pouch.
The proposed Hall® Smart Guard® Irrigator is also an accessory/attachment to a powered instrument system that provides irrigation at the surgical site. It is an injectionmolded, polypropylene sleeve that fits over the bur guard on the distal tip of the handpiece. A stainless steel, single-lumen tube is insert-molded into the sleeve and can be attached to irrigation tubing to direct fluid to the surgical site. Irrigation inflow is controlled by a pump integral to the console. The proposed attachments will be available as sterile, single use devices. The Hall® Smart Guard® Irrigator will be packaged in a Twek®/poly pouch.
The polypropylene contains a thermochromatic dye that changes color when the internal temperature of the bur guard reaches 135° F and before the external temperature of the Hall® Smart Guard®Irrigator reaches 122°. This feature provides a heat indicator that serves two purposes:
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Rose 2 of 2
510(k) Summary Hall® Smart Guard® Irrigator January 10, 2007
-
- The temperature of the bur guard increases when the bearings are worn. It will alert the user that the bur guard should be serviced.
-
- It will alert the user that the temperature of the Hall® Smart Guard® Irrigator has increased to the point that could result in potential patient injury.
In addition, the Hall® Smart Guard® Irrigator provides thermal insulation to the patient from heat that may be generated by the bur guard. The sleeve provides insulation to the patient by virtue of the physical barrier between the bur quard and the patient.
F. Intended Use
The Hall® Smart Guard® Irrigator is an accessory to a powered instrument system consisting of drills, saws and associated handpieces to perform the cutting of soft tissue and bone. The fields of application include: orthopedic, arthroscopic, neurosurgical, otolaryngological, plastic/reconstructive and oral/maxillofacial procedures.
G. Substantial Equivalence
The Hall® Smart Guard® Irrigator is substantially equivalent in scientific technology, design and intended use to the Universal Drive System and the MicroPower handpieces. The Universal Drive System was cleared by FDA under 501(k) K971059. Modifications to the Universal Drive System were cleared under special 510(k) numbers K060198, MicroPower Handpiece Medium Speed Drill; K060260, MicroPower Handpiece High Speed Drill; and K060270, MicroPower Handpiece Oral Max High Speed Drill. The changes made to the legally marketed devices have been tested to assure that the proposed modifications do not raise any new issues of safety and efficacy.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features an eagle-like emblem with three stylized lines representing feathers. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the emblem.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
ConMed Linvatec % Ms. Elizabeth Paul Manager, Regulatory Affairs 11311 Concept Boulevard Largo, Florida 33773-4908
APR - 2 2007
Re: K070233
Trade/Device Name: Hall® Smart Guard® Irrigator Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: II Product Code: HRX Dated: March 9, 2007 Received: March 12, 2007
Dear Ms. Paul:
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 – Ms. Elizabeth Paul
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 vours.
Murk N Millham
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
| 510(k) Number (if known): | K070233 |
|---|---|
| Device Name: | Hall® Smart Guard® Irrigator |
Indications for Use:
The Hall®Smart Guard® Irrigator is an accessory to a powered instrument system consisting of drills, saws and associated handpieces to perform the cutting of soft tissue and bone. The fields of application include: orthopedic, arthroscopic, neurosurgical, otolaryngological, plastic/reconstructive and oral/maxillofacial procedures.
Prescription Use _ V (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A. Allman
Page 1 of 1
Division of General, Restorative, and Neurological Devices
510(k) Number
§ 888.1100 Arthroscope.
(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.