(50 days)
The SURGICHIP Tag is intended to mark an anatomical site for surgery.
The SURGICHIP Tag surgical marker is indicated to mark an anatomical site for surgery.
The SURGICHIP™ Tag smart label and procedure that uses Radio Frequency Identification technology to mark an anatomical site prior to surgery. It is designed to be used in addition to the usual safeguards so that the correct procedure is performed on the correct site and on the intended patient.
The provided text describes a 510(k) submission for the SURGICHIP™ Tag Surgical Marker. However, it does not contain the detailed information required to fill out a table of acceptance criteria and reported device performance, nor does it describe a study with the specific parameters requested.
The document primarily focuses on:
- Device Description: The SURGICHIP™ Tag uses Radio Frequency Identification (RFID) to mark an anatomical site prior to surgery, supplementing existing safeguards to ensure correct procedure, site, and patient.
- Intended Use/Indications for Use: To mark an anatomical site for surgery.
- Substantial Equivalence: The device is deemed substantially equivalent to a Skin Marker, an Adhesive Surgical Site Marker, and a RFID Hospital Identification Wristband. The document states, "Testing of the subject device demonstrated that the SURGICHIP Tag is an effective method of marking a surgical site prior to surgery and is equivalent to the predicate devices."
Missing Information:
The document does not provide:
- Specific acceptance criteria (e.g., quantitative performance metrics, thresholds for accuracy, reliability, etc.).
- Any details about the "testing" mentioned, such as study design, methodology, sample sizes, data provenance, ground truth establishment, expert involvement, or statistical analysis.
- Results in a format suitable for a "reported device performance" section with specific metrics.
- Information about multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
- Details about training sets if an AI/algorithm-based device were involved (which, based on the description, is not the primary function of this RFID tag).
Conclusion:
Based on the provided text, it's not possible to generate the requested table or describe the study in detail because the document is a 510(k) summary focused on substantial equivalence rather than a detailed report of a performance study with specific acceptance criteria and results. The "testing" mentioned is referred to only in a broad statement, without any supporting data or methodology.
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- 510(k) Summary of Safety and Effectiveness
| SUBMITTER: | SURGICHIP, Inc.4398 Hickory DrivePalm Beach Gardens, FL 33418 |
|---|---|
| CONTACT PERSON: | Bruce Waxman, M.D.President |
| DATE PREPARED: | September 1, 2004 |
| CLASSIFICATION NAME: | Skin Marker |
| COMMON NAME: | Skin Marker |
| PROPRIETARY NAME: | SURGICHIP™ Tag |
| PREDICATE DEVICES: | Skin Marker (Sec. 878.4660) |
| DEVICE DESCRIPTION: | The SURGICHIP™ Tag smart label and procedure that usesRadio Frequency Identification technology to mark ananatomical site prior to surgery. It is designed to be used inaddition to the usual safeguards so that the correct procedureis performed on the correct site and on the intended patient. |
| INTENDED USE: | The SURGICHIP Tag is intended to mark an anatomical sitefor surgery. |
SUMMARY:
The SURGICHIP Tag is substantially equivalent to a Skin Marker, an Adhesive Surgical Site Marker, and a RFID Hospital Identification Wristband. These devices are identical with regard to their intended use. SURGICHIP Tag, the Skin Marker, and the Adhesive Surgical Site Marker differ in some degree in their technological characteristics but they all mark a surgical site prior to surgery and they act to provide another level of confirmation for the surgical team prior to operating on the patient. The SURGICHIP Tag and the RFID Hospital Identification Wristband use the identical technological characteristics to corroborate that the correct surgery will be performed on the correct patient and the correct body part by displaying patient and surgical procedure specific information.
Testing of the subject device demonstrated that the SURGICHIP Tag is an effective method of marking a surgical site prior to surgery and is equivalent to the predicate devices.
NOV - 9 2004
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Image /page/1/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 image of an eagle or bird-like figure with three wing-like lines extending upwards.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 9 2004
Bruce Waxman, M.D. President SURGICHIP, Inc. 4398 Hickory Drive Palm Beach Gardens, Florida 33418
Re: K042555
Trade/Device Name: SURGICHIP™ Tag Surgical Marker Regulation Number: 21 CFR 878.4660 Regulation Name: Skin marker Regulatory Class: I Product Code: FZZ Dated: October 28, 2004 Received: November 1, 2003
Dear Dr. Waxman:
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- Bruce Waxman, M.D.
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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam 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
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Indications for Use
510(k) Number (if known): KO42555
SURGICHIP™ Tag Surgical Marker Device Name:
Indications for Use:
The SURGICHIP Tag surgical marker is indicated to mark an anatomical site for surgery.
XXX :_________________________________________________________________________________________________________________________________________________________________________ Prescription Use (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)
Muriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________
Page 1 of 1
(Posted November 13, 2003)
§ 878.4660 Skin marker.
(a)
Identification. A skin marker is a pen-like device intended to be used to write on the patient's skin, e.g., to outline surgical incision sites or mark anatomical sites for accurate blood pressure measurement.(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 the limitations in § 878.9.