(46 days)
Not Found
No
The summary describes a simple insulation tester and does not mention any AI or ML components or capabilities.
No
The device is described as an "Insulation Tester" that "checks for insulation integrity on laparoscopic instruments". Its function is to test the integrity of medical instruments, not to provide therapy to a patient.
No.
The device is an insulation tester for laparoscopic instruments, designed to check the integrity of the insulation, not to diagnose a medical condition in a patient.
No
The device description and performance testing clearly indicate a physical "Insulation Tester" that interacts with laparoscopic instruments, implying hardware components are involved in the testing process.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "check for insulation integrity on laparoscopic instruments." This is a test performed on a medical device (a laparoscopic instrument) to ensure its proper function and safety, not a test performed on a biological sample (blood, urine, tissue, etc.) to diagnose a disease or condition in a patient.
- Device Description: It's described as an "Insulation Tester." This further reinforces its function as a testing device for equipment, not for biological samples.
- Lack of IVD Characteristics: The description lacks any mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information about a patient's health status.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not fit that description.
N/A
Intended Use / Indications for Use
"The Spectrum Insulation Tester checks for insulation integrity on laparoscopic instruments"
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
"Insulation Tester"
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
"In actual test performance, real world conditions were simulated by modifying a laparoscopic shaft to include a small pin hole and also to abrade the surface in an area. These are the two scenarios that would typically be found, however any area not properly insulated would be detected by the insulation tester. A minimum of 30 tests in each condition over 2 different time periods were chosen to be performed in order to assure randomness. 180 tests were completed in all, which was well above the minimum number of verification testing requirements. The insulation tester had a 100% success rate in being able to detect insufficient insulation while not rejected known good insulated laparoscopic shafts."
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
"The insulation tester had a 100% success rate in being able to detect insufficient insulation while not rejected known good insulated laparoscopic shafts."
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.
Jac-Cell Medic K020334
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
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.
0
MAR 2 7 2012
Ki20416
Section 5: 510k) Summary
The Summary of Safety and Effectiveness information on the Insulation Tester is heing submitted in accordance with the requirements of 21 C.F.R. 8807.92 and reflects data available and represented at the time the submission was prepared, but caution should be exercised in interpreting the data. The results of future studies and or tests may require alterations of the conclusions or
recommendations set forth.
| Applicant | Spectrum Surgical Instruments |
|---|---|
| 4575 Hudson Drive | |
| Stow Ohio 44224 | |
| Telephone | 330-686-4550 |
| Facsimile | 330-686-4555 |
| Date | December 9, 2011 |
| Name | Dennis A. Kovit Director of Operations |
| Classification | Electrosurgical, cutting and coagulation and accessories. |
| Predicate: | Jac-Cell Medic K020334 |
| Description: | Insulation Tester |
| Intended Use | Verify insulation integrity on laparoscopic instruments |
| Contraindication: | |
| Warning | Should not be used by or in the presence of someone with an electrical implanted device, such as a pace maker. |
| Technological Characteristics | This device generates an electrical current and detects the current when there is insufficient insulation covering a laparoscopic instrument. |
| Performance Testing | In actual test performance, real world conditions were simulated by modifying a laparoscopic shaft to include a small pin hole and also to abrade the surface in an area. These are the two scenarios that would typically be found, however any area not properly insulated would be detected by the insulation tester. A minimum of 30 tests in each condition over 2 different time periods were chosen to be performed in order to assure randomness. 180 tests were completed in all, which was well above the minimum number of verification testing requirements. The insulation tester had a 100% success rate in being able to detect insufficient insulation while not rejected known good insulated laparoscopic shafts. |
| Substantial | ||||
|---|---|---|---|---|
| Equivalency | ||||
| Information | Measured Values | |||
| Conditions / Spectrum | ||||
| Specifications | Spectrum | |||
| Insulation Tester | Jac-Cell Medic | |||
| K020334 | Comments | |||
| Normal (open) Batt. @ 9V |
- 32 - 40 mA | 34.5mA | 38.2mA | Spectrum lower = longer
Batt. life. |
| | Normal (open) Batt. @ 9V
2200 - 2400 Volts | 2.330 Volts | 2.374 Volts | Slight voltage diff.
performance is same |
| | Normal (open) Batt. @ 7V -
32 - 40 mA | 34.5mA | 30.9mA | Not at 7V for long period of
time. Low Battery. |
| | Normal (open) Batt. @ 7v -
2200 - 2400 Volts | 2.330 Volts | 2.015 Volts | Spectrum voltage stable
through 7V |
P. 1 of 2
1
| | Fault (short) Batt. @ 9V -
115 - 145mV | 132mA | 158mA | Spectrum lower longer Batt.
life. |
|------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|----------------|----------------------------------------------------|
| | Fault (short) Batt. @ 7V -
115 - 145 mA | 132mA | 108mA | Not at 7V for long period of
time. Low Battery. |
| | Fault Detection | Red LED, Sound | Red LED, Sound | Spectrum & Jac-Cell Equal |
| | Low Battery Indicator | Red LED | Red LED | Spectrum and Jac-Cell Equal |
| Conclusion | The Spectrum insulation tester is equivalent to the Jac-Cell Medic insulation and
continuity tester with respect to insulation testing. Since the Spectrum tester does
not test for continuity, no statement can be made in this regard | | | |
$\rho.2/2$
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized, curved lines.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Spectrum Surgical Instruments, Corporation % Mr. Dennis A. Kovit Director of Repair Operations 4575 Hudson Drive Stow, Ohio 44224-1725
Re: K120416
Trade/Device Name: Insulation Tester Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: March 1, 2012 Received: March 6, 2012
Dear Mr. Kovit:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
MAR 2 7 2012
3
Page 2 - Mr. Dennis A. Kovit
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
For Peter De. Lid Dr.
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K120416
Insulation Tester Device Name:
Indications For Use: The Spectrum Insulation Tester checks for insulation integrity on laparoscopic instruments
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)
Nil R.P. Ogden for mxn
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
Page 1 of 1
. 510(k) Number K120416