(169 days)
Not Found
No
The summary describes a mechanical electrosurgical device and its performance in simulated tissue studies. There is no mention of AI, ML, image processing, or any data-driven algorithms.
Yes
The device is used for amputating the uterus and resecting myomas, which are therapeutic medical interventions.
No
The device is an electrosurgical device for amputating tissue, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a 5 mm single use laparoscopic instrument with physical dimensions and materials, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical procedure (amputating the uterus and resecting myomas) using an electrosurgical device. This is a therapeutic and surgical application, not a diagnostic test performed on samples outside the body.
- Device Description: The device is described as a surgical instrument (a bipolar loop) used during a laparoscopic procedure.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health status.
- Performance Study: The performance study focuses on the cutting quality and time of the device in simulated tissue, which is relevant to its surgical function, not its diagnostic accuracy.
IVD devices are designed to perform tests on samples taken 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 LiNA Bipolar Loop is a 5mm bipolar electrosurgical device intended for amputating the mobilized uterus during laparoscopic supracervical (subtotal) hysterectomy and resection of devasculated subserosal pedunculated myomas. To be used with an electrosurgical generator that provides a bipolar outlet.
Product codes
HIN
Device Description
The LiNA Bipolar Loop is a 5 mm single use laparoscopic instrument. It is available with three different loop dimensions; 160mm x 80mm, 200mm x 100mm x 120mm x 120mm. The outer 15mm on each side of the loop is not insulated i.e. the bipolar cutting area length totals 30mm. The device is single use ethylene oxide sterilized and is compatible with most standard electrosurgical generators that provide a bipolar outlet.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Uterus (mobilized uterus), subserosal pedunculated myomas
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)
Efficacy and Functionality Test: The LiNA Loop and the LiNA Bipolar Loop had similar cutting quality in simulated tissue study using pork and beef muscle. Cutting quality was assessed on a scale of 1-9, with 5 being the acceptance criteria. 200mm sized loops were selected as this represented the mid-size loop for both the Bipolar Loop and Loop. The loops were assessed for cutting quality at high and low power settings. Both devices were qualitatively scored as a 5. Furthermore, cutting time was assessed, with an average deviation time between cuts of 0.85 seconds. Cutting time was assessed at the respective high and low power settings using three different generators and found to be within acceptable limits (±4 seconds). Therefore, the cutting time and quality were equivalent between the LiNA Loop and the LiNA Bipolar Loop.
The LiNA Bipolar Loop meets all the requirements for overall design, sterilization, biocompatibility, and electrical safety confirms that the output meets the design inputs and specifications. The LiNA Bipolar Loop passed all testing stated above as shown by the acceptable results obtained.
The LiNA Bipolar Loop complies with the applicable voluntary standards for biocompatibility and sterilization. The device passed all the testing in accordance with national and international standards.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 884.4150 Bipolar endoscopic coagulator-cutter and accessories.
(a)
Identification. A bipolar endoscopic coagulator-cutter is a device used to perform female sterilization and other operative procedures under endoscopic observation. It destroys tissue with high temperatures by directing a high frequency electrical current through tissue between two electrical contacts of a probe. This generic type of device may include the following accessories: an electrical generator, probes, and electrical cables.(b)
Classification. Class II. The special controls for this device are:(1) FDA's:
(i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”
(ii) “510(k) Sterility Review Guidance 2/12/90 (K-90),” and
(iii) “Guidance (‘Guidelines’) for Evaluation of Laproscopic Bipolar and Thermal Coagulators (and Accessories),”
(2) International Electrotechnical Commission's IEC 60601-1-AM2 (1995-03), Amendment 2, “Medical Electrical Equipment—Part 1: General Requirements for Safety,”
(3) American National Standards Institute/American Association for Medical Instrumentation's HF-18, 1993, “Electrosurgical Devices,”
(4) Labeling:
(i) Indication: For female tubal sterilization, and
(ii) Instructions for use:
(A) Destroy at least 2 centimeters of the fallopian tubes,
(B) Use a cut or undampened sinusoidal waveform,
(C) Use a minimum power of 25 watts, and
(D) For devices with ammeters: continue electrode activation for 5 seconds after the visual endpoint (tissue blanching) is reached or current flow ceases indicating adequate tissue destruction.
0
LiNA Medical ApS Traditional 510(k) Premarket Submission LiNA Bipolar Loop
EMERGO GROUP
Section 5 - 510(k) Summary
1. Submission Sponsor
JUL 2 4 2013
- LiNA Medical ApS Formervangen 5 2600 Glostrup Denmark Phone: +45 4329 6666 Fax: +45 4329 6699 Contact: Louisa Memborg, Regulatory Affairs Officer
2. Submission Correspondent
Emergo Group 611 West 5th Street, Third Floor Austin, TX 78701 Cell Phone: (406) 579-8124 Office Phone: (512) 327.9997 Fax: (512) 327.9998 . Contact: Richard Gillis, Ph.D., Senior Consultant Email: project.management@emergogroup.com
3. Date Prepared
27 JAN 2013
Device Identification 4.
| Trade/Proprietary Name: | LiNA Bipolar Loop |
|---|---|
| Common/Usual Name: | Bipolar electrosurgical Loop |
| Classification Name: | Bipolar Endoscopic coagulator-cutter and accessories |
| Classification Regulation: | 21 CFR 884.4150 |
| Product Code: | HIN |
| Device Class: | Class II |
| Classification Panel: | Obstetrics and Gynecology Panel |
5. Predicate Devices
6. Device Description
The LiNA Bipolar Loop is a 5 mm single use laparoscopic instrument. It is available with three different loop dimensions; 160mm x 80mm, 200mm x 100mm x 120mm x 120mm. The outer 15mm on each side of the loop is not insulated i.e. the bipolar cutting area length
1
totals 30mm. The device is single use ethylene oxide sterilized and is compatible with most standard electrosurgical generators that provide a bipolar outlet.
7. Intended Use
The LiNA Bipolar Loop is a 5mm bipolar electrosurgical device intended for amputating the mobilized uterus during laparoscopic supracervical hysterectomy and resection of devasculated subserosal pedunculated myomas. To be used with an electrosurgical generator that provides a bipolar outlet.
8. Comparison of Technological Characteristics
The following table compares the LiNA Bipolar Loop to the predicate devices with respect to intended use, technological characteristics and principles of operation, providing more detailed information regarding the basis for the determination of substantial equivalence.
| Manufacturer | LiNA Medical ApS
Formervangen 5
2600 Glostrup
Denmark | LiNA Medical ApS
Formervangen 5
2600 Glostrup
Denmark | Gyrus ACMI, Inc
136 Turnpike Rd.
Southborough, MA
01772-2104 |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | LINA Bipolar Loop | LINA Loop | PKS BILL |
| 510(k) Number | TBD | K070315 | K111059 |
| Product Code | HIN | KNF | HIN |
| Regulation
Number | 21 CFR 884.4150 | 21 CFR 884.4160 | 21 CFR 884.4150 |
| Regulation Name | Bipolar endoscopic
coagulator-cutter and
accessories | Coagulator-cutter,
endoscopic, unipolar
(and accessories) | Bipolar endoscopic
coagulator-cutter and
accessories |
| Indications for
Use | The LiNA Bipolar Loop is
a 5mm bipolar
electrosurgical device
intended for amputating
the mobilized uterus
during laparoscopic
supracervical (subtotal)
hysterectomy and
resection of
devasculated subserosal
pedunculated myomas.
To be used with an
electrosurgical generator
that provides a bipolar
outlet. | The LiNA Loop is a
5mm monopolar
electrosurgical device
intended for
sectoring the
mobilized uterus
during Laparoscopic
supracervical
hysterectomy. To be
used with an
electrosurgical
generator | The PKS BILL is a 5mm
bipolar electrosurgical
device intended for
sectoring the mobilized
uterus during
Laparoscopic
supracervical
hysterectomy and the
resection of
devasculated subserosal
pedunculated myomas.
Working in conjunction
with Gyrus ACMI
generator |
| Material | 1. Gold plated stainless
steel wire with
molded zirconia
ceramic tin and | 1. Stainless steel wire | According to PKS BILL
510(k), K111059
summary "Uses
materials that are well |
Table 5A - Comparison of Characteristics
2
EMERGO GROUP
| Manufacturer | LiNA Medical ApS | LiNA Medical ApS | Gyrus ACMI, Inc |
|---|---|---|---|
| Formervangen 5 | |||
| 2600 Glostrup | |||
| Denmark | Formervangen 5 | ||
| 2600 Glostrup | |||
| Denmark | 136 Turnpike Rd. | ||
| Southborough, MA | |||
| 01772-2104 | |||
| Trade Name | LiNA Bipolar Loop | LiNA Loop | PKS BILL |
| established". | |||
| polyamide cap. |
- Shrink tube: FEP
(Teflon) - Funnel: Black
polyamide - Cannula/Fibre tube:
Vinyl ether resin with
fiberglass
reinforcement - Inner cannula Tube:
Kynar® - Handle: ABS
- Cable: Thermoplastic
polyurethane with
brass connector. | 2. Shrink tube:
Kynar®(PVDF) - Funnel: Black
polyamide - Fibre tube: Vinyl
ether resin with
fiberglass
reinforcement - Inner cannula
Tube: Kynar® - Handle: ABS
- Cable: PVC with
brass connector. | |
| Sterile | Sterile packed.
Ethylene Oxide Gas
SAL 10-6 | Sterile packed.
Ethylene Oxide Gas
SAL 10-6 | Sterile packed.
Gamma Irradiation.
SAL 10-6 |
| Single-Use | Intended for single use
only. | Intended for single
use only. | Intended for single use
only. |
| Shelf Life | 3 years | 3 years | Unknown |
| Battery Operated | N/A | N/A | N/A |
| AC Powered | N/A | N/A | N/A |
| Complies with ISO
10993-1 | Yes | Yes | Yes |
| Electrical Safety
Testing Passed | IEC 60601 | IEC 60601 | IEC 60601 |
Non-Clinical Performance Data 9.
The following testing has been performed to support substantial equivalence:
- Efficacy and Functionality Test The LiNA Loop and the LiNA Bipolar Loop had similar . cutting quality in simulated tissue study using pork and beef muscle. Cutting quality was assessed on a scale of 1-9, with 5 being the acceptance criteria. 200mm sized loops were selected as this represented the mid-size loop for both the Bipolar Loop and Loop. The loops were assessed for cutting quality at high and low power settings. Both devices were qualitatively scored as a 5. Furthermore, cutting time was assessed, with an average deviation time between cuts of 0.85 seconds. Cutting time was assessed at the respective high and low power settings using three different generators and found to be within acceptable limits (±4 seconds). Therefore, the cutting time and quality were equivalent between the LiNA Loop and the LiNA Bipolar Loop.
3
As part of demonstrating the safety and effectiveness of the LINA Bipolar Loop and in showing substantial equivalence the predicate devices that are subject to this 510(k) submission, LiNA Medical ApS completed a number of tests. The LiNA Bipolar Loop meets all the requirements for overall design, sterilization, biocompatibility, and electrical safety confirms that the output meets the design inputs and specifications. The LiNA Bipolar Loop passed all testing stated above as shown by the acceptable results obtained.
The LiNA Bipolar Loop complies with the applicable voluntary standards for biocompatibility and sterilization. The device passed all the testing in accordance with national and international standards.
10. Clinical Testing
There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. These types of devices, including the predicate devices, have been on the market for many years with a proven safety and efficacy for the use of the device. The non-clinical testing detailed in this submission supports the substantial equivalence of the device.
11. Statement of Substantial Equivalence
lt has been shown in this 510(k) submission that the difference between the LiNA Bipolar Loop and the predicate devices do not raise any questions regarding its safety and effectiveness. Performance testing and compliance with voluntary standards, demonstrate that the LiNA Bipolar Loop is substantially equivalent to the relevant aspects of the predicate devices in terms of design, components, materials, principals of operation, sterilization, biocompatibility, performance characteristics, and intended use. The LiNA Bipolar Loop, as designed and manufactured, is determined to be substantially equivalent to the referenced predicate devices.
4
Image /page/4/Picture/0 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 design featuring three abstract shapes resembling an eagle or bird in flight.
Public Health Service
Food and Drug Administration 10903 New Hamoshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 24, 2013
LiNA Medical ApS % Richard Gillis, Ph.D. Senior Regulatory Consultant Emergo Group, Inc. 611 West 5th Street, Third Floor Austin, TX 78701
Re: K130305
Trade/Device Name: LiNA Bipolar Loop Regulation Number: 21 CFR 884.4150 Regulation Name: Bipolar endoscopic coagulator-cutter and accessories Regulatory Class: Class II Product Code: HIN Dated: June 07, 2013 Received: June 10, 2013
Dear Richard Gillis, Ph.D.,
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 cither 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
5
Page 2 - Richard Gillis, Ph.D.
comply with all the Act's requirements. including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its to!!-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Herbert P. Lerner -S
for
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
· Enclosure
6
Section 4 - Indications for Use Statement
510(k) Number (if known): Not Assigned K130305
Device Name: LiNA Bipolar Loop
Indications for Use:
The LiNA Bipolar Loop is a 5mm bipolar electrosurgical device intended for amputating the mobilized uterus during laparoscopic supracervical (subtotal) hysterectomy and resection of devasculated subserosal pedunculated myomas. To be used with an electrosurgicol generator that provides a bipolar outlet.
Prescription Use_x (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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)