(324 days)
Not Found
No
The device description and intended use focus on manually operated surgical instruments and accessories, with no mention of AI or ML capabilities.
Yes
The document states that the instruments are intended for "therapeutic and minimally invasive general surgical procedures" for various actions like "grasping, manipulating, retracting, cutting, suturing, occluding or clamping soft tissue," and the electrodes are for "coagulation and transection of soft tissue," all of which are considered therapeutic actions.
No
The document describes various laparoscopic instruments (forceps, scissors, cannulas, needle holders, etc.) used for surgical procedures like grasping, manipulating, cutting, suturing, and coagulating tissue, as well as providing suction/irrigation. These are therapeutic and surgical tools, not devices intended for diagnosing conditions.
No
The device description clearly outlines a family of physical, manually operated surgical instruments and accessories made of materials like stainless steel, PTFE, and PEEK. It also mentions testing related to mechanical stress, dielectric strength, and electromagnetic interference, which are characteristic of hardware devices. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the devices as surgical instruments used for manipulating, cutting, grasping, and other actions on soft tissue within the body during laparoscopic procedures. This is a direct surgical intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details physical surgical instruments like forceps, scissors, trocars, etc., made of materials suitable for surgical use.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, etc.) outside of the body to provide diagnostic information. The device's function is entirely focused on performing surgical actions.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
The ELMED Laparoscopic Instruments are intended for use in a variety of laparoscopic/endoscopic, therapeutic and minimally invasive general surgical procedures for grasping, manipulating, retracting, cutting, suturing, occluding or clamping soft tissue.
The Laparoscopic Electrodes are electrosurgical devices intended to be used for a variety of general laparoscopic procedures through a port, for coagulation and transection of soft tissue by use of high frequency electric current.
Manually operated surgical instruments are available with or without monopolar high frequency connection and are designed to be used through an opening maintained by a cannula which allows inserting and removal of the instrument(s) without damaging the tissue(s).
Bipolar Forceps are designed to grasp, manipulate and coagulate selected soft tissue and are intended for use in general surgical procedures. They are connected through a suitable bipolar cable with the bipolar output of an electrosurgical generator.
Suction/ Irrigation Cannulas have an application(s) in laparoscopic procedures such as gynecologic, general, thoracic and urology and are intended to provide suction and irrigation to help flush blood and tissue debris from the operative site during laparoscopy to aid visualization.
Trocars and Trocar Sleeves are intended to create portals into an operative site for the direct visualization and/or inserting of other surgical instruments.
Needle holders are intended to grasp and manipulate needles inside the peritoneal cavity enabling a surgeon to suture internal soft tissue during a laparoscopic procedure.
Instruments should be used only by personnel completely familiar with their operation.
Product codes (comma separated list FDA assigned to the subject device)
GCJ, GEI
Device Description
These devices represent a family of Laparoscopic/Endoscopic Instruments and Accessories that consist of:
- . Laparoscopic Monopolar electrodes
- . Laparoscopic Bipolar forceps
- Laparoscopic Trocars, Trocar sleeves
- . Laparoscopic Needle Holders
- . Laparoscopic Suction/ Irrigation Cannulas
- . Laparoscopic Suture and Ligature Instruments
- . Laparoscopic various manually operated surgical instruments with and without monopolar high frequency connection ( scissors, graspers/dissectors, biopsy forceps)
- . Laparoscopic Accessories such as: Cleaning Brushes, Sealing Caps, Adapters
Various configurations, sizes and handles of the jaws (graspers, forceps, scissors, dissectors, biopsy, and punches) exist to meet the needs of surgical procedures in conjunction with a laparoscope/endoscope. The instruments have the capability for monopolar RF current, if needed. These instruments are composed of biocompatible materials (surgical grade stainless steel, PTFE, PEEK, several coatings, silicon and brass chromium plated). These materials have a long history of biocompatibility for human use at short term contact. The instruments are reusable and sold non-sterile.
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
Instruments should be used only by personnel completely familiar with their operation. / 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)
Non-clinical testing was conducted, including Mechanical Stress Testing, Mechanical Push/Pull Testing, Drop Testing, Dielectric Strength Testing, Capacitive Coupling Testing, Leakage Current Testing, and Electromagnetic Interference/Immunity Testing. The results demonstrate that ELMED Laparoscopic Instruments and Accessories are as safe and effective as the predicate device.
No prospective clinical studies were conducted as the indications for use, technology, and materials of construction are virtually identical to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
0
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March 22, 2019
ELMED Incorporated Werner Hausner President 35 N Brandon Drive Glendale Heights, Illinois 60139
Re: K181173
Trade/Device Name: ELMED Laparoscopic Instruments and Accessories Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ, GEI Dated: February 20, 2019 Received: February 21, 2019
Dear Werner Hausner:
We have reviewed vour 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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 adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Image /page/1/Picture/5 description: The image shows a digital signature from Long H. Chen -S. The signature indicates that the document was digitally signed on March 22, 2019. The timestamp of the signature is 10:05:03 -04'00'. The signature is for something.
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K181173
Device Name ELMED LAPAROSCOPIC INSTRUMENTS AND ACCESSORIES
Indications for Use (Describe)
The ELMED Laparoscopic Instruments are intended for use in a variety of laparoscopic/endoscopic, therapeutic and minimally invasive general surgical procedures for grasping, manipulating, retracting, cutting, suturing, occluding or clamping soft tissue.
The Laparoscopic Electrodes are electrosurgical devices intended to be used for a variety of general laparoscopic procedures through a port, for coagulation and transection of soft tissue by use of high frequency electric current.
Manually operated surgical instruments are available with or without monopolar high frequency connection and are designed to be used through an opening maintained by a cannula which allows inserting and removal of the instrument(s) without damaging the tissue(s).
Bipolar Forceps are designed to grasp, manipulate and coagulate selected soft tissue and are intended for use in general surgical procedures. They are connected through a suitable bipolar cable with the bipolar output of an electrosurgical generator.
Suction/ Irrigation Cannulas have an application(s) in laparoscopic procedures such as gynecologic, general, thoracic and urology and are intended to provide suction and irrigation to help flush blood and tissue debris from the operative site during laparoscopy to aid visualization.
Trocars and Trocar Sleeves are intended to create portals into an operative site for the direct visualization and/or inserting of other surgical instruments.
Needle holders are intended to grasp and manipulate needles inside the peritoneal cavity enabling a surgeon to suture internal soft tissue during a laparoscopic procedure.
Instruments should be used only by personnel completely familiar with their operation.
Type of Use (Select one or both, as applicable)
| × Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
Section 5: 510(k) Summary
These 510(k) summary is being submitted in accordance with 21 CFR §807.92.
Type of submission: Traditional
The assigned 510 (k) number is: K181173
A. Company Contact
ELMEDINCORPORATED 35 N Brandon Drive Glendale Heights, IL 60139
- B. Submitter Information: Werner Hausner
President ELMEDINCORPORATED werner@elmed.com
C. Identification of theDevice:
| Proprietary Name: | ELMED Laparoscopic Instruments and Accessories |
|---|---|
| Common Name: | Laparoscopic Instrument and Accessory |
| Classification Name: | Laparoscope, General and Plastic surgery |
| Product Code: | GCJ |
| Secondary Product Code: | GEI |
| Regulatory Class: | Class II 21 CFR 876.1500 |
| Panel: | General and Plastic Surgery |
D. Identification of the Predicate Device
Legally Marketed Equivalent Devices
| Manufacturer | Brand Name | 510(k)
Number |
|---------------------------------|-----------------------------------------------------------------------------------------------|------------------|
| JAKOUBEK
MEDIZINTECHNIK GMBH | TROCAR & TROCAR SLEEVES, LAPAROSCOPES,
LAPAROSCOPIC FORCEPS, & LAPAROSCOPIC
INSTRUMENTS | K990785 |
| HANS HERMANN GMBH | HANS HERMANN LAPAROSCOPES AND ACCESSORIES | K051610 |
Table 1: Predicative Device Information
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E. Device Description:
These devices represent a family of Laparoscopic/Endoscopic Instruments and Accessories that consist of:
- . Laparoscopic Monopolar electrodes
- . Laparoscopic Bipolar forceps
- Laparoscopic Trocars, Trocar sleeves
- . Laparoscopic Needle Holders
- . Laparoscopic Suction/ Irrigation Cannulas
- . Laparoscopic Suture and Ligature Instruments
- . Laparoscopic various manually operated surgical instruments with and without monopolar high frequency connection ( scissors, graspers/dissectors, biopsy forceps)
- . Laparoscopic Accessories such as: Cleaning Brushes, Sealing Caps, Adapters
Various configurations, sizes and handles of the jaws (graspers, forceps, scissors, dissectors, biopsy, and punches) exist to meet the needs of surgical procedures in conjunction with a laparoscope/endoscope. The instruments have the capability for monopolar RF current, if needed. These instruments are composed of biocompatible materials (surgical grade stainless steel, PTFE, PEEK, several coatings, silicon and brass chromium plated). These materials have a long history of biocompatibility for human use at short term contact. The instruments are reusable and sold non-sterile.
F. Intended Use and Indication for Use of the subject device(s):
The ELMED Laparoscopic Instruments are intended for use in a variety of laparoscopic/endoscopic, therapeutic and minimally invasive general surgical procedures for grasping, dissecting, manipulating, retracting, suturing, occluding or clamping soft tissue.
The Laparoscopic Electrodes are electrosurgical devices intended to be used for a variety of general laparoscopic procedures through a port, for coagulation and transection of soft tissue by use of high frequency electric current. Manually operated surgical instruments are available with or without monopolar
high frequency connection and are designed to be used through an opening maintained by a cannula which allows inserting and removal of the instrument(s) without damaging the tissue(s).
5
Bipolar Forceps are designed to grasp, manipulate and coagulate selected soft tissue and are intended for use in general surgical procedures. They are connected through a suitable bipolar cable with the bipolar output of an electrosurgical generator.
Suction/ Irrigation Cannulas have an application(s) in laparoscopic procedures such as gynecologic, general, thoracic and urology and are intended to provide suction and irrigation functions to help flush blood and tissue debris from the operative site during laparoscopy to aid visualization.
Trocars and Trocar Sleeves are intended to create portals into an operative site for the direct visualization and/or inserting of other surgical instruments. Needle holders are intended to grasp and manipulate needles inside the peritoneal cavity enabling a surgeon to suture internal soft tissue during a laparoscopic procedure.
Instruments should be used only by personnel completely familiar with their operations.
G. Non-clinical Testing
The devices conform to IEC 60601-2-2 . Testing conducted on the instruments also included but was not limited to:
-
- Mechanical Stress Testing
-
- Mechanical Push/Pull Testing
-
- Drop Testing
-
- Dielectric Strenght Testing
- Capacitive Coupling Testing 5.
-
- Leakage Current Testing
-
- Electromagnetic Interference/Immunity Testing
The results also demonstrate that ELMED Laparoscopic Instruments and Accessories are as safe and effective as the predicate device.
H. Clinical Testing
There were no prospective clinical studies to support the medical device as the indications for use, technology: materials of construction are virtually identical to the predicate device. The non-clinical testing detailed in this submission supports the substantial equivalence of the device.
I. Substantial Equivalence/ Conclusion
By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device.
The differences between the predicates and the modified design do not raise any new risks of safety or efficacy. The changes are minor, so the subject devices are as safe and effective as the predicate devices, perform similarly to other legally marketed predicate devices for laparoscopic/endoscopic and minimally invasive procedure. ELMED Laparoscopic Instruments and Accessories are as safe and effective as the predicate device.