(263 days)
The text does not list any Reference Devices.
No
The document describes traditional surgical instruments and accessories without any mention of AI or ML capabilities.
Yes
The document describes several devices that cut, dissect, manipulate, cauterize, and filter contaminants during surgical procedures, all of which are actions intended to treat or alleviate disease or injury.
No
The listed devices are surgical instruments and accessories (scissors, forceps, trocars, smoke filters, needles, suction/irrigation sets) used for mobilization, transection, access, or filtration during endoscopic procedures. Their intended use is to perform surgical actions, not to diagnose medical conditions by providing information about the presence, absence, or state of a disease or condition.
No
The device description clearly outlines physical, disposable surgical instruments (scissors, forceps, trocars, etc.) made of biocompatible materials and sterilized using a gamma procedure. There is no mention of software as a component or the primary function of the device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses described are for surgical procedures (gynecological, general, vascular, abdominal, thoracic) involving the manipulation, cutting, dissecting, and cauterizing of tissues, as well as establishing entry points and managing smoke and fluids during these procedures. These are all actions performed on the patient's body during surgery.
- Device Description: The devices are described as surgical instruments (scissors, forceps, trocars, needles, suction/irrigation sets) used within the body during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body) to provide information about a physiological state, health, or disease.
IVD devices are used to test samples like blood, urine, or tissue to diagnose or monitor conditions. The devices described here are surgical tools used directly on the patient during a procedure.
N/A
Intended Use / Indications for Use
The Advanced Medical Monopolar Scissors, Maryland Dissecting Forceps, Lap Clinch, Rat Tooth LapClinch, Babcock, Straight Grasping Forceps with Ratchet are indicated for use in gynecological and general endoscopic procedures for mobilization and transection of tissues. The device with a 5mm diameter insulated shaft has a male cautery connection on top of the handle and may be used for monopolar cautery when attached to standard cautery cables and their generators
The Advanced Medical Reducer has application in gynecologic laparoscopy and other abdominal procedures and is designed to be used with the Advanced Medical Disposable Surgical Trocar to allow the surgeon to insert undersized instruments through the Trocar without losing insufflation.
The Advanced Medical Laparoscopic Smoke Filter is intended for the filtration of contaminants from smoke, generated during laparoscopic surgery, which can contain volatile organic products of combustion (including those which are perceived as odor) and particulates (including cellular debris, bacteria and viruses).
The Advanced Medical Hasson Trocar and Dilating Tip Trocar has application in thoracic, gynecologic laparoscopy, and other abdominal procedures to establish a path of entry for endoscopic instruments.
The Advanced Medical Shielded Trocar has application in thoracic, gynecologic laparoscopy, and other abdominal procedures to establish a path of entry for endoscopic instruments. Instruments provided with a stopcock are intended for insufflation of the operative space when the trocar is in place.
The Advanced Medical Secondary Trocar and Sleeve with Insufflation Port are manual surgical instruments used to support a cut down (lap approach).
The Secondary Trocar is used in endoscopic surgery (abdominal and thoracic) for incision and peritoneal access for positioning of the hollow sleeve. Once the trocar is removed, the port of entry provided by the sleeve, through the cap, is used with manual surgical instruments, endoscopic instruments, laparoscopes and probes. There is a seal on the cap which closes the port of entry.
The Advanced Medical Stainless Steel Veress Needle is for the initial induction of pneumoperitoneum.
The Advanced Medical Suction/Irrigation Set is intended for use in endoscopic procedures such as laparoscopy, pelviscopy, and thorascopy, for suctioning of large clots, retrieving spilled stones, high flow irrigation and hydro-dissection.
Product codes
GEI, HET, GCJ
Device Description
The Advanced Medical Innovations Disposable Trocars and Laparoscopic Accessories can be used in a variety of procedures (general, vascular, gynecological and surgical procedures) to cut, dissect, manipulate and/or cauterize various tissues. Trocars are sterile, single-use devices that allow visualization of body cavities and use of the laparoscopic accessories.
The accessory devices are disposable, single use, individually packaged devices that are composed of biocompatible materials. Scissors, forceps, and dissectors have a handle attached to an insulated shaft with different tips, which allows the shaft and tip to rotate. They include a male cautery connector when attached to standard monopolar cautery cables and their generators. All devices are sterilized using a traditional, validated gamma procedure per AAMI/ISO International standard 11137 (EN 552) to a SAL of 10-6.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gynecological, general, abdominal, thoracic
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
Non-Clinical Tests: Advanced Medical disposable trocars and laparoscopic accessories met the electrical, safety, EMC, and applicable testing requirements of IEC 60601-2-2:2006 4th Edition. None of the testing demonstrated any design characteristics that violated the requirements of the standards or resulted in any safety hazards.
Clinical Tests: Clinical testing was not conducted.
Key Metrics
Not Found
Predicate Device(s)
K071976, K040295, K062169, K940439, K971837, K020428, K904907, K964450, K992361
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
FEB - 6 2009
Page 1 of 5
510(K) SUMMARY
This summary of 5l0(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 510(k) number is:________________________________________________________________________________________________________________________________________________
Submitter's Identification: 1.
| Contact: | Mike Hoftman |
|---|---|
| Company Name: | Advanced Medical Innovations |
| Address: | 9410 De Soto Avenue, Bldg J |
| Chatsworth, CA 91311 | |
| Tel: | 818-701-7180 |
| Fax: | 818-701-9708 |
Date Prepared:
February 3, 2009
-
- Name of the Device: Advanced Medical Innovations Disposable Trocars and Laparoscopic Accessories
These disposable devices include: Monopolar Scissors, Maryland Dissecting Forceps, Straight Grasping Forceps, Straight Grasping Forceps with Ratchet, Lapclinch with Ratchet, Rat Tooth Lapclinch with Ratchet, Babcock, Suction Irrigation Set, Trocars (Auto Shield, Hasson, Secondary and Dilating Tip), Veress Needles, Flip Top Reducer and Laparoscopic Smoke Filter.
- Name of the Device: Advanced Medical Innovations Disposable Trocars and Laparoscopic Accessories
-
Electrosurgical, Cutting & Coagulation & 3. Common Name: Accessories 878.4400 Regulation: Product Code: GEI
Common Name: Laparoscopic, Gynecologic and accessories Regulation: 884.1720-Product Code: HET
1
KO 81 398
Page 2 of 5
.
1
:
.
.
i
.
4. Predicate Device Information and Comparison:
:
: : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : :
. 1
.
.
| Device
Description | Predicate Device | 510(k)
Number | Comparison |
|------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| American
Medical
Innovations
Disposable
Trocars and
Laparoscopic
Accessories | VECTEC Bioparc,
France. VECTEC
Disposable Trocars
and Laparoscopic
Accessories | K071976 | Both our subject device
and the predicate
device are similar in
their basic
characteristics. |
| Scissors,
Forceps,
Dissectors,
Hook,
Lapclinch,
Babcock | Applied Medical
Resources Corp. | K040295 &
K062169 | The predicate device is
basically identical to our
subject device with the
exception of the tip
design which is based
on physician's
preference |
| Suction
Irrigation Set | Conmed . Gleeson
FloVac Hand
controlled Suction
Irrigation
Instrument. | K940439 | The subject device(s)
are basically identical to
the predicate device
with respect to
technological
characteristics and
function. |
| Veress
Needles | Northgate
Technologies, Inc
Veress Needle | K971837 | The predicate device is
basically identical to the
subject device. |
| Dilating Tip
Trocars,
Autoshield
Trocars and
Hasson
Trocars | Ethicon Endo-
Surgery Inc -
ENDOPATH Trocar | K020428 | Both our subject device
and the predicate
device are basically
identical. |
| Flip Top
Reducer | Ethicon, Inc.
Endopath
(Disposable
Surgical Trocar
Reducer | K904907 | Both our subject device
and the predicate
device are basically
identical. |
| Secondary
Trocar | Pilling Weck
Secondary Trocar
with a plastic
Sleeve and
Insufflation Port | K964450 | Both our subject device
and the predicate
device are basically
identical. |
| Smoke Filter | Pall Medical
Laparoscopic
Smoke Filtration
System | K992361 | Both our subject device
and the predicate
device are basically
identical. |
2
Page 3 of 5
5. Device Description:
The Advanced Medical Innovations Disposable Trocars and Laparoscopic Accessories can be used in a variety of procedures (general, vascular, gynecological and surgical procedures) to cut, dissect, manipulate and/or cauterize various tissues. Trocars are sterile, single-use devices that allow visualization of body cavities and use of the laparoscopic accessories.
The accessory devices are disposable, single use, individually packaged devices that are composed of biocompatible materials. Scissors, forceps, and dissectors have a handle attached to an insulated shaft with different tips, which allows the shaft and tip to rotate. They include a male cautery connector when attached to standard monopolar cautery cables and their generators. All devices are sterilized using a traditional, validated gamma procedure per AAMI/ISO International standard 11137 (EN 552) to a SAL of 10-6.
6. Intended Use/Indications for Use
The Advanced Medical Monopolar Scissors, Maryland Dissecting Forceps, Lap Clinch, Rat Tooth LapClinch, Babcock, Straight Grasping Forceps with Ratchet are indicated for use in gynecological and general endoscopic procedures for mobilization and transection of tissues. The device with a 5mm diameter insulated shaft has a male cautery connection on top of the handle and may be used for monopolar cautery when attached to standard cautery cables and their generators
The Advanced Medical Reducer has application in gynecologic laparoscopy and other abdominal procedures and is designed to be used with the Advanced
3
Page 4 of 5
Medical Disposable Surgical Trocar to allow the surgeon to insert undersized instruments through the Trocar without losing insufflation.
The Advanced Medical Laparoscopic Smoke Filter is intended for the filtration of contaminants from smoke, generated during laparoscopic surgery, which can contain volatile organic products of combustion (including those which are perceived as odor) and particulates (including cellular debris, bacteria and viruses).
The Advanced Medical Hasson Trocar and Dilating Tip Trocar has application in thoracic, gynecologic laparoscopy, and other abdominal procedures to establish a path of entry for endoscopic instruments.
The Advanced Medical Shielded Trocar has application in thoracic, gynecologic laparoscopy, and other abdominal procedures to establish a path of entry for endoscopic instruments. Instruments provided with a stopcock are intended for insufflation of the operative space when the trocar is in place.
The Advanced Medical Secondary Trocar and Sleeve with Insufflation Port are manual surgical instruments used to support a cut down (lap approach).
The Secondary Trocar is used in endoscopic surgery (abdominal and thoracic) for incision and peritoneal access for positioning of the hollow sleeve. Once the trocar is removed, the port of entry provided by the sleeve, through the cap, is used with manual surgical instruments, endoscopic instruments, laparoscopes and probes. There is a seal on the cap which closes the port of entry.
The Advanced Medical Stainless Steel Veress Needle is for the initial induction of pneumoperitoneum.
The Advanced Medical Suction/Irrigation Set is intended for use in endoscopic procedures such as laparoscopy, pelviscopy, and thorascopy, for suctioning of large clots, retrieving spilled stones, high flow irrigation and hydro-dissection.
4
K 0 81398
Page 5-g(5)
Discussion of Non-Clinical Tests Performed for Determination of 7. Substantial Equivalence are as follows:
Advanced Medical disposable trocars and laparoscopic accessories met the electrical, safety, EMC, and applicable testing requirements of IEC 60601-2-2:2006 4th Edition .
None of the testing demonstrated any design characteristics that violated the requirements of the standards or resulted in any safety hazards.
8. Discussion of Clinical Tests Performed:
Clinical testing was not conducted.
9. Conclusions:
Based on the information provided in this submission we conclude that the Advanced Medical Disposable Trocars and Laparoscopic Accessories are substantially equivalent to the predicates and is safe and effective for its intended use.
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the 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 an abstract image of an eagle.
Public Health Service
FEB = 6 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Advanced Medical Innovations, Inc. % MDI Consultants, Inc. Ms. Maria F. Griffin 55 Northern Boulevard, Suite 200 Great Neck, New York 11021
Re: K081398
Trade/Device Name: Advanced Medical Disposable Trocar and Laparoscopic Accessories Regulation Number: 21 CFR 878.4400
Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II
Product Code: GEI, HET, GCJ
Dated: January 28, 2009
Received: January 29, 2009
Dear Ms. Griffin:
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
6
Page 2 - Ms. Maria F. Griffin
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.
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Mark N. Wilkinson
- Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
FEB - 6 2009
Attachment A
Indications for Use
Page of 2
K081398 510(k) Number (if known):
Device Name: Advanced Medical Disposable Trocar and Laparoscopic Accessories
Indications For Use:
The Advanced Medical Monopolar Scissors, Maryland Dissecting Forceps, Lap Clinch, Rat Tooth LapClinch, Babcock, Straight Grasping Forceps with Ratchet are indicated for use in gynecological and general endoscopic procedures for mobilization and transection of tissues. The device with a 5mm diameter insulated shaft has a male cautery connection on top of the handle and may be used for monopolar cautery when attached to standard cautery cables and their generators
The Advanced Medical Reducer has application in gynecologic laparoscopy and other abdominal procedures and is designed to be used with the Advanced Medical Disposable Surgical Trocar to allow the surgeon to insert undersized instruments through the Trocar without losing insufflation.
The Advanced Medical Laparoscopic Smoke Filter is intended for the filtration of contaminants from smoke, generated during laparoscopic surgery, which can contain volatile organic products of combustion (including those which are perceived as odor) and particulates (including cellular debris, bacteria and viruses).
The Advanced Medical Hasson Trocar and Dilating Tip Trocar has application in thoracic, gynecologic laparoscopy, and other abdominal procedures to establish a path of entry for endoscopic instruments.
Prescription Use X
(Per 21 CFR 801 Subpart D)
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)
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number
8
FEB = 6 2009
Attachment A
Indications for Use
Page 2 of of 22
510(k) Number (if known): _ KO8 | 398
Device Name: The Advanced Medical Disposable Trocar and Laparoscopic Accessories
Indications For Use:
The Advanced Medical Shielded Trocar has application in thoracic, gynecologic laparoscopy, and other abdominal procedures to establish a path of entry for endoscopic instruments. Instruments provided with a stopcock are intended for insufflation of the operative space when the trocar is in place.
The Advanced Medical Secondary Trocar and Sleeve with Insufflation Port are manual surgical instruments used to support a cut down (lap approach).
The Secondary Trocar is used in endoscopic surgery (abdominal and thoracic) for incision and peritoneal access for positioning of the hollow sleeve. Once the trocar is removed, the port of entry provided by the sleeve, through the cap, is used with manual surgical instruments, endoscopic instruments, laparoscopes and probes. There is a seal on the cap which closes the port of entry.
The Advanced Medical Stainless Steel Veress Needle is for the initial induction of pneumoperitoneum.
The Advanced Medical Suction/Irrigation Set is intended for use in endoscopic procedures such as laparoscopy, pelviscopy, and thorascopy, for suctioning of large clots, retrieving spilled stones, high flow irrigation and hydro-dissection.
Prescription Use (Per 21 CFR 801 Subpart D)
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)
(Division Sign-Off Of Chine of General, Restorative, Ind Neurological Devices
510(k) Number