INTROMIT HAND ACCESS PORT FOR HAND ASSISTED LAPAROSCOPIC SURGERY, MODEL FP880-150

K990663 · Medtech , Ltd. · GCJ · May 27, 1999 · Gastroenterology, Urology

Device Facts

• Record ID: K990663
• Device Name: INTROMIT HAND ACCESS PORT FOR HAND ASSISTED LAPAROSCOPIC SURGERY, MODEL FP880-150
• Applicant: Medtech , Ltd.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: May 27, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Intromit™ is intended to be used as a port into surgical sites. The Intromit™ is inserted into the patient's abdomen to provide abdominal access for a surgeon's hand while preserving the pneumoperitoneum during laparoscopic surgery.

Device Story

Intromit™ is a flexible hand access port for minimally invasive surgery (MIS). Device consists of an access tube with inner/outer polymer sleeves and an adhesive flange. Surgeon marks incision site using template, inserts distal end into abdominal cavity, and adheres flange to skin to create pressure-tight seal. Insufflation gas is administered through a valve; pressure forces inner sleeve walls together to form a distal seal, while a tapered proximal end seals against the surgeon's forearm. Device allows surgeon to insert hand/forearm into abdomen while maintaining pneumoperitoneum. Used in clinical settings by surgeons. Benefits include minimized trauma, ease of access, and maintenance of laparoscopic advantages like shorter recovery compared to open surgery.

Clinical Evidence

Clinical study of 44 patients compared hand-assisted laparoscopic colectomies (HALC) using Intromit™ vs. standard laparoscopic colectomies (LC) with trocars. Results showed HALC procedure time was at least as short as LC; conversion rates to open surgery were equivalent; instrument change requirements were similar; morbidity and hospital stays were equivalent; and direct hospital costs were no higher for HALC. Bench testing confirmed tensile strength of sleeves, valves, and flange. Skin sensitization testing in guinea pigs showed no positive responses.

Technological Characteristics

Flexible access tube kit comprising polymer film sleeves (inner/outer) and adhesive-coated flange. Features include insufflation valve, distal taut valve, and proximal tapered seal. Materials are medical grade. Single-patient use; sterile packaging (double Tyvek pouches). No electronic components; purely mechanical/pneumatic operation.

Indications for Use

Indicated for patients undergoing laparoscopic surgery requiring hand-assisted access to the abdominal cavity.

Regulatory Classification

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.

Special Controls

*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.

In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls: 1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following: 1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures. 2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use. 3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use. 2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes. 3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches 4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error. 5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program. (6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms. (7) Labeling must include: (i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified; (ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA; (iii) Identification of compatible devices; (iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification; (v) Reprocessing instructions for reusable components; (vi) A shelf life for any sterile components; (vii) A description of the device-specific use training program; (viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and (ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance. (8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include: (i) Device motion accuracy and repeatability; (ii) System testing; (iii) Instrument reliability; (iv) Crosstalk; (v) Table motion control; (vi) Thermal effects on tissue; (vii) User-device interface performance; (viii) Workspace access testing; and (ix) Performance testing with compatible devices. (9) Software verification, validation, and hazard analysis must be performed. (10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed. (11) Performance data must demonstrate the sterility of all patient-contacting device components. (12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life. (13) Performance data must validate the reprocessing instructions for the reusable components of the device. (14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible. (15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic. (16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information: (i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and (ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.

Predicate Devices

• Pilling Weck's Dexterity® Pneumo Sleeve and Protector® Retractor
• Karl Storz Endoscopy America, Inc.'s trocars and cannulas
• Solos Endoscopy Inc. GS-4300 Cannula and Trocar
• Solos Endoscopy Inc. GS-4500 Cannula and Trocar
• Marlow Surgical Technologies Hasson SAC Cannula
• Ethicon, Inc.'s Endopath Trocar
• Innerdyne Medical 'Step' Radical Expansion Obturator/Cannula

Submission Summary (Full Text)

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MAY 27 toon

# 510(k) Summary

# MEDTECH LIMITED'S INTROMITTM HAND ACCESS PORT FOR HAND ASSISTED LAPAROSCOPIC SURGERY

# Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

- Martin Caldwell Medtech Limited Unit 3 70 Heather Road Sandyford Industrial Estate Dublin 18 Ireland
Phone: [phone] Facsimile: 011-353-1-294-3319

Contact Person:

Jonathan S. Kahan Hogan & Hartson 555 13th Street, N.W. Washington, DC 20004

[phone] Phone: Facsimile: [phone]

Regulatory Counsel to Medtech Limited

Date Prepared: May 4, 1999

## Name of Device:

Intromit™ Hand Access Port for Hand Assisted Laparoscopic Surgery

## Common or Usual Name:

Surgical Access Port

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### Classification Name:

Endoscopic Accessory - Extended Laparoscopy Device

#### Product Code: GCJ

#### Predicate Devices:

- 1. Pilling Weck's Dexterity® Pneumo Sleeve and Protector® Retractor;
- 2. Karl Storz Endoscopy America, Inc.'s trocars and cannulas for endoscopic and laparoscopic procedures;
- 3. Solos Endoscopy Inc. GS-4300 Cannula and Trocar and GS-4500 Cannula and Trocar:
- 4. Marlow Surgical Technologies Hasson SAC Cannula;
- 5. Ethicon, Inc.'s Endopath Trocar; and
- 6. Innerdyne Medical 'Step' Radical Expansion Obturator/Cannula.

### Intended Use

Intromit™ is intended to be used as a port into surgical sites. The Intromit™ is inserted into the patient's abdomen to provide abdominal access for a surgeon's hand while preserving the pneumoperitoneum during laparoscopic surgery.

#### Principles of Operation

Intromit™ is a hand access port for use in Minimally Invasive Surgery (MIS). The aim of the designers of Intromit™ was to minimize the trauma to the patient while permitting ease of access to an inflated abdomen. By creating a device whereby the incision required is no larger than that necessary to allow passage of the surgeon's hand and forearm, the first criterion has been achieved. The single handed entry method, with no external clamping or sealing mechanism, has ideally achieved the second criterion. The flexible nature of Intromit™ makes it universal in relation to the size of a surgeon's arm and the depth of insertion into the abdomen.

Intromit™ is easy to use. The incise template is used to mark the location and size of the incision and the perimeter of the adhesive flange site. An incision is made through the patient's abdominal wall into the abdominal cavity. The distal end of the inner sleeve is inserted into the abdominal cavity through the incision. The flange is adhered to the patient's skin using the drawn perimeter line as a guide to its application, creating a pressure-tight seal. Insufflation gas is then

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administered through the insufflation valve into the access tube, which makes it easier for the surgeon to insert his or her hand through it into the abdomen.

The insufflation pressure forces the walls of the inner sleeve together at two points, which forms pressure-tight seals. The distal end of the inner sleeve contains a taut valve that forces the walls of the sleeve together, creating a seal in the abdominal cavity. In addition, the proximal end of the access tube is tapered to produce a seal between its lip edge and the surgeon's forearm or wrist. The active seal maintains the abdominal pressure by preventing gas from escaping through the mouth of the access tube.

#### Technological Characteristics

Intromit™ will be sold as a kit that includes a flexible access tube, medical grade adhesive, sterile lubricant and incise template. The access tube consists primarily of an outer sleeve, an inner sleeve, and an adhesive coated flange, which is welded to the distal end of the outer sleeve. The inner and outer sleeves are welded together. The principal components of the access tube are made of polymer film. Intromit™ is packaged into sterile double tyvek pouches and is labeled as a single-patient use device.

#### Substantial Equivalence

Intromit™ has the same intended use as Pilling Weck's Dexterity® Pneumo Sleeve and Protector® Retractor. Both devices to be inserted into the patient's abdomen to provide abdominal access for a surgeon's hand while preserving the pneumoperitoneum during laparoscopic surgery. Both the predicate device and Intromit™ achieve this in similar fashion: both comprise a flexible polymer sleeve that when adhesively attached to the patients abdomen, form an extension to the abdomen; both have distal and proximal seals and means of affording protection at the incision site; and both utilize similar materials and manufacturing methods in their construction.

Both Intromit™ and Dexterity® are similar in the way in which they retain pneumoperitoneal pressure during laparoscopic surgery in that they are nominally cylindrical, gas impermeable, flexible polymer sleeves with an integral adhesive flange for sealing and attachment to the patients abdomen. Both incorporate two sealing means, (1) a proximal seal for the containment of pressurized gas with a surgeon's arm passing through the device and (2) a distal seal for the containment of pressurized gas in the absence of a surgeon's arm. In addition, both devices contain a mechanism for protection of the mini-laparotomy incision by way of a polymer film barrier that exists between the incision and the access lumen for the surgeon's "gloved" hand and forearm.

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Intromit™ also has the same general intended use as its predicate device trocars and cannulas, listed above. As with the Intromit™, these devices are indicated for laparoscopic surgery using gas pressure to distend the abdominal cavity. These predicate devices have similar principles of operation and technological characteristics, namely they provide access into the surgical site and insufflation gas may be administered through several of the predicate devices, in order to maintain abdominal gas pressure.

### Performance Data

Both nonclinical and clinical testing have been conducted on Intromit™. Bench testing has been successfully performed on each component of Intromit™ in order to ensure that the components function as intended during use (i.e., tensile strength testing was conducted on the Intromit™'s outer sleeve, inner sleeve, feather valve, flange, and taut valve). The Intromit™ material was also evaluated for its ability to cause skin sensitization in guinea pigs, and no positive skin responses were obtained for any of the guinea pigs. A clinical study was then conducted to compare hand assisted laparoscopic colectomies ("HALC") with the Intromit™ and standard laparoscopic colectomies ("LC") with trocars. Forty four patients were enrolled in the study. This study showed that:

- The overall procedure time for HALC with the Intromit™ is at least as short as the overall procedure time for LC with trocars;
- Patients in the Intromit™ device group are no more likely to convert to open . surgery than patients in the LC group;
- No more instrument changes are required for HALC with the Intromit™ than . LC with trocars:
- The one death that occurred during the clinical trial was not related to the . Intromit™ device;
- The morbidity for HALC with the Intromit™ is equivalent to the morbidity for . LC with trocars;
- The direct hospital costs associated with HALC using the Intromit™ are no . higher, and possibly lower, than the direct hospital costs associated with LC using trocars;
- The hospital stays for patients who receive HALC with the Intromit™ are . equivalent to the hospital stays for patients who receive LC with trocars; and

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- The HALC with the Intromit™ has retained one of the major advantages of . laparoscopic surgery, i.e., a shorter reconvalescence when compared to open surgery.
Thus, the clinical study shows that the HALC with the Intromit™ are as safe and effective as LC with trocars.

#### Conclusion

Based on a narrative comparison of the Intromit™, the Dexterity® device, and the trocars as summarized above and the clinical data which also is summarized above, Intromit™ is substantially equivalent to its predicate devices.

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features three wavy lines that resemble a stylized human figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the caduceus symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 7 1000

Medtech, Limited c/o Mr. Jonathan S. Kahan, Esq. Hogan & Hartson, L.L.P. Columbia Square 555 Thirteenth Street, NW Washington, D.C. 20004

K990663 Re:

Trade Name: Intromit® Hand Access Port for Hand Assisted Laparoscopic Surgery Regulatory Class: GCJ Product Code: II Dated: March 1, 1999 Received: March 1, 1999

Dear Mr. Kahan:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 – Mr. Jonathan S. Kahan, Esq.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):__K990663

Device Name: Medtech Ltd.'s Intromit Hand Access Port

Indications for Use:

The Intromit is inserted into the patient's abdomen to provide abdominal access for the surgeon's hand while preserving the peritoneum during laparoscopic surgery.

(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 Devices K990663.
510(k) Number

Prescription Use
(Per 21 C.F.R. 801.109)
OR
Over-The-Counter Use

(Optional Format 1-2-96)