(289 days)
Not Found
No
The device description and performance studies focus on mechanical and electrical components, with no mention of AI or ML algorithms for image processing, data analysis, or decision-making.
No
The device is described as a surgical tool used for cutting, coring, and extracting tissue (morcellation) during laparoscopic procedures, which is an operative function, not a therapeutic one in the sense of treating a disease or condition.
No
This device is described as a surgical tool for cutting, coring, and extracting tissue. It performs an operative function rather than providing diagnostic information.
No
The device description clearly outlines a physical, single-use, disposable device with a motor, battery, cutting blade, and other hardware components. The performance studies also focus on the physical aspects and functionality of the hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "cutting, coring and extracting tissue in operative laparoscopy." This describes a surgical procedure performed on the patient, not a test performed on a sample taken from the patient.
- Device Description: The description details a surgical instrument used for tissue removal during surgery. It does not mention any components or functions related to analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing samples, detecting analytes, providing diagnostic information, or any other characteristic typically associated with IVD devices.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening. This device is used to remove tissue during a surgical procedure, not to analyze it afterwards for diagnostic purposes.
N/A
Intended Use / Indications for Use
The LiNA Xcise Laparoscopic Morcellator is intended for gynaecologic endoscopic use by trained professionals in hospital and surgical clinic environments.
Indicated for cutting, coring and extracting tissue in operative laparoscopy, including gynaecologic procedures such as hysterectomy and myomectomy.
Product codes
HET
Device Description
The LiNA Xcise Laparoscopic Morcellator is a single use, fully disposable, device that is supplied sterile. It has a self contained motor-unit and battery power-supply in a pistol grip housing with a trigger to control blade rotation and an integrated adjustable trocar housing containing a rotating cylindrical tube 15mm in diameter sharpened on the distal end to a cutting blade. The trocar housing is manually retractable to expose the cutting blade. The device includes duckbill housing with valve to restrict gas leakage. The morcellator is to be used with standard tissue graspers that are extended through the cylindrical tube to grasp the tissue to be morcellated by pulling it through the rotating blade in a coring action. The device is single packed in blister package with tyvek lid. The package includes an obturator.
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
trained professionals in hospital and surgical clinic environments.
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)
Testing has been carried out with respect to:
Test of cutting tube
Test of trocar and trocar function
Test of gearing/toothed wheels lifetime
Test of motor, torque, motor-lifetime and morcellation functionality
Test of ergonomics and trigger function
Test of battery lifetime and electronics
Test of battery post gamma sterilization
Test of environment: Heat, vibration and noise
Test of pull strength cutting tube
Test of torque
Test of speed (RPM)
Test of EMC per EN 60601-1-2: 2007 FCC 47 CFR part 18
Test cut rate g/minute
No clinical data was deemed necessary to support this premarket notification. However, published literature is provided to demonstrate the safe and effective use of morcellation devices used for tissue removal during hysterectomy.
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
§ 884.1720 Gynecologic laparoscope and accessories.
(a)
Identification. A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for gynecologic laparoscope accessories that are not part of a specialized instrument or device delivery system, do not have adapters, connector channels, or do not have portals for electrosurgical, lasers, or other power sources. Such gynecologic laparosope accessory instruments include: the lens cleaning brush, biopsy brush, clip applier (without clips), applicator, cannula (without trocar or valves), ligature carrier/needle holder, clamp/hemostat/grasper, curette, instrument guide, ligature passing and knotting instrument, suture needle (without suture), retractor, mechanical (noninflatable), snare, stylet, forceps, dissector, mechanical (noninflatable), scissors, and suction/irrigation probe. 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 § 884.9.
0
K101458 pe
LiNA eXcise 510(k) Submission to FDA
5. 510(k) Summarv
[As required by 21 CFR 807.92]
Submitted by
LiNA Medical ApS Formervangen 5 2600 Glostrup Denmark .. Phone: +45 4329 6666 Fax: +45 4329 6699
Louisa Memborg, Regulatory Affairs Officer
5/27/2010
LiNA Xcise Laparoscopic Morcellator
Soft Tissue Morcellator and Accessories
Laparoscope, Gynecologic (and accessories)
Predicate device(s) name, number, date cleared
(1)Gynecare laparoscopic Morcellator [GYNECARE X-TRACT Tissue Morcellator] K993801, cleared on 02/07/2000 (2) SEMM SET FOR MOTO DRIVE WISAP #7689 SSM (MODIFICATION) K960640, cleared on 02/14/1997
Intended Use
The LiNA Xcise Laparoscopic Morcellator is intended for gynaecologic endoscopic use by trained professionals in hospital and surgical clinic environments.
Description of Device
The LiNA Xcise Laparoscopic Morcellator is a single use, fully disposable, device that is supplied sterile. It has a self contained motor-unit and battery power-supply in a pistol grip housing with a trigger to control blade rotation and an integrated adjustable trocar housing containing a rotating cylindrical tube 15mm in diameter sharpened on the distal end to a cutting blade. The trocar housing is manually retractable to expose the cutting blade. The device includes duckbill housing with valve to restrict gas leakage. The morcellator is to be used with standard tissue graspers that are extended through the cylindrical tube to grasp the tissue to be morcellated by pulling it through the rotating
10 | Page
21458 2331
May 27, 2010
MAR 1 1 2011
Contact person
Date Prepared
Device trade name
Common name
Classification name
1
blade in a coring action. The device is single packed in blister package with tyvek lid. The package includes an obturator.
Indications For Use
Indicated for cutting, coring and extracting tissue in operative laparoscopy, including gynaecologic procedures such as hysterectomy and myomectomy.
Technological Characteristics
The essential technological characteristics of the device are substantially the same as the predicate devices.
Performance Data
Testing has been carried out with respect to:
Test of cutting tube
Test of trocar and trocar function
Test of gearing/toothed wheels lifetime
Test of motor, torque, motor-lifetime and morcellation functionality
Test of ergonomics and trigger function
Test of battery lifetime and electronics
Test of battery post gamma sterilization
Test of environment: Heat, vibration and noise
Test of pull strength cutting tube
Test of torque
Test of speed (RPM)
Test of EMC per EN 60601-1-2: 2007 FCC 47 CFR part 18
Test cut rate g/minute
Clinical Data
No clinical data was deemed necessary to support this premarket notification. However, published literature is provided to demonstrate the safe and effective use of morcellation devices used for tissue removal during hysterectomy.
Substantial Equivalence Conclusions
The LiNA Xcise Laparoscopic Morcellator device does not raise any new issues of safety, effectiveness, or performance of the product. Based on the 510(k) summaries and information presented herein we have concluded that the LiNA Xcise Laparoscopic Morcellator is substantially equivalent to the Predicate Device(s) under the Federal Food, Drug, and Cosmetic Act.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three heads, representing the three branches of government. The eagle is surrounded by a circle of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
LiNA Medical ApS c/o Mr. Walter L. Brittle, Jr. Managing Partner FDA Compliance Help Desk, Inc. 1289 N. Fordham Blvd.. Suite A-128 CHAPEL HILL NC 27517
MAR 1 1 2011
Re: K101458
Trade Name: LiNA Xcise™ Laparoscopic Morcellator Regulation Number: 21 CFR §884.1720 Regulation Name: Gynecologic laparoscope and accessories Regulatory Class: II Product Code: HET Dated: February 25, 2011 Received: March 1, 2011
Dear Mr. Brittle:
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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related
3
Page 2
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/CDRH/CDRHOffices/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 yours,
Hubert Lemire MD
Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health.
Enclosure
4
4. Indications for Use Statement
Indications for Use
510(k) Number (if known): K101458
Device Name: LiNA Xcise™ Laparoscopic Morcellator
Indications for Use:
Indicated for cutting, coring and extracting tissue in operative laparoscopy, including gynaecologic procedures such as hysterectomy and myomectomy.
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)
Page 1 of __
(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K101458