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.

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.

AI/ML Overview

This submission describes the "Advanced Medical Innovations Disposable Trocars and Laparoscopic Accessories". Based on the provided text, the device is considered substantially equivalent to predicate devices, and no clinical trials were conducted to establish new acceptance criteria or performance metrics distinct from the predicates.

Here's a breakdown of the information requested, as extractable from the provided document:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Electrical Safety (IEC 60601-2-2:2006 4th Edition)	Met the requirements of IEC 60601-2-2:2006 4th Edition.
General Safety (Implied by standard compliance)	Met the requirements of IEC 60601-2-2:2006 4th Edition. No design characteristics violated requirements or resulted in safety hazards.
Electromagnetic Compatibility (EMC) (Implied by standard compliance)	Met the requirements of IEC 60601-2-2:2006 4th Edition.
Sterilization Assurance Level (SAL) of 10^-6	Devices are sterilized using a traditional, validated gamma procedure per AAMI/ISO International standard 11137 (EN 552) to a SAL of 10^-6.
Biocompatibility	Composed of biocompatible materials (stated for accessory devices).
Functional Equivalence to Predicate Devices	Devices are "basically identical" or "similar in their basic characteristics" to predicate devices, with some minor differences (e.g., tip design for scissors/forceps based on physician's preference). This is the primary "performance" metric for a 510(k) submission not involving new clinical data.

Study Information

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Test Set Sample Size: Not applicable. The document explicitly states "Clinical testing was not conducted." The non-clinical testing for electrical, safety, and EMC would have used a sample size determined by the specific testing protocols for those standards, but this information is not provided in a way that relates to an "AI test set" or patient data.
- Data Provenance: Not applicable, as no clinical data was used for a test set.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable, as no clinical testing or "test set" requiring expert ground truth was conducted for this 510(k) submission.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable, as no clinical testing or "test set" requiring adjudication was conducted.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC or comparative effectiveness study was done. This is not an AI device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable, as this is a medical device (surgical instruments), not an AI algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical tests (electrical, safety, EMC), the "ground truth" was compliance with established international standards (IEC 60601-2-2) and sterile processing standards (AAMI/ISO 11137). For the substantial equivalence argument, the ground truth was the performance and characteristics of the legally marketed predicate devices.
The sample size for the training set:
- Not applicable, as this is a medical device, not an AI model requiring a training set.
How the ground truth for the training set was established:
- Not applicable, as this is a medical device, not an AI model requiring a training set.

In summary: The submission for the "Advanced Medical Innovations Disposable Trocars and Laparoscopic Accessories" relies on demonstrating substantial equivalence to already cleared predicate devices and compliance with relevant non-clinical performance standards (electrical safety, EMC, sterilization). No clinical studies or AI-related evaluations (training sets, test sets, expert ground truth, MRMC studies) were conducted or reported for this submission.

Summary

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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 JChatsworth, CA 91311
Tel:	818-701-7180
Fax:	818-701-9708

Date Prepared:

February 3, 2009

1. 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.
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

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KO 81 398

Page 2 of 5

4. Predicate Device Information and Comparison:

: : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : :

. 1

DeviceDescription	Predicate Device	510(k)Number	Comparison
AmericanMedicalInnovationsDisposableTrocars andLaparoscopicAccessories	VECTEC Bioparc,France. VECTECDisposable Trocarsand LaparoscopicAccessories	K071976	Both our subject deviceand the predicatedevice are similar intheir basiccharacteristics.
Scissors,Forceps,Dissectors,Hook,Lapclinch,Babcock	Applied MedicalResources Corp.	K040295 &K062169	The predicate device isbasically identical to oursubject device with theexception of the tipdesign which is basedon physician'spreference
SuctionIrrigation Set	Conmed . GleesonFloVac Handcontrolled SuctionIrrigationInstrument.	K940439	The subject device(s)are basically identical tothe predicate devicewith respect totechnologicalcharacteristics andfunction.
VeressNeedles	NorthgateTechnologies, IncVeress Needle	K971837	The predicate device isbasically identical to thesubject device.
Dilating TipTrocars,AutoshieldTrocars andHassonTrocars	Ethicon Endo-Surgery Inc -ENDOPATH Trocar	K020428	Both our subject deviceand the predicatedevice are basicallyidentical.
Flip TopReducer	Ethicon, Inc.Endopath(DisposableSurgical TrocarReducer	K904907	Both our subject deviceand the predicatedevice are basicallyidentical.
SecondaryTrocar	Pilling WeckSecondary Trocarwith a plasticSleeve andInsufflation Port	K964450	Both our subject deviceand the predicatedevice are basicallyidentical.
Smoke Filter	Pall MedicalLaparoscopicSmoke FiltrationSystem	K992361	Both our subject deviceand the predicatedevice are basicallyidentical.

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K081398

Page 3 of 5

5. Device Description:

6. Intended Use/Indications for Use

The Advanced Medical Reducer has application in gynecologic laparoscopy and other abdominal procedures and is designed to be used with the Advanced

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K081398

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 Secondary Trocar and Sleeve with Insufflation Port are manual surgical instruments used to support a cut down (lap approach).

The Advanced Medical Stainless Steel Veress Needle is for the initial induction of pneumoperitoneum.

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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.

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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

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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

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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:

Prescription Use X
(Per 21 CFR 801 Subpart D)

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

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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 Secondary Trocar and Sleeve with Insufflation Port are manual surgical instruments used to support a cut down (lap approach).

The Advanced Medical Stainless Steel Veress Needle is for the initial induction of pneumoperitoneum.

Prescription Use (Per 21 CFR 801 Subpart D)

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

Regulation Number and Section

§ 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.