(87 days)
Not Found
Not Found
No
The device description and performance studies focus on the mechanical and material properties of a surgical access device, with no mention of AI or ML.
No
The device provides abdominal access for surgery and does not directly treat a disease or medical condition.
No
The device provides abdominal access for surgery and does not perform any diagnostic function.
No
The device description clearly outlines physical components (flexible access tube, adhesive, lubricant, incise template) made of polymer film, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The Intromit is used in vivo (inside the patient's body) to provide surgical access. IVD devices are used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a surgical access device, not a test or reagent used to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or providing diagnostic information based on laboratory testing.
The Intromit is a surgical instrument used during laparoscopic procedures.
N/A
Intended Use / 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
GCJ
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Abdomen
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon, hospital setting (implied by laparoscopic surgery)
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)
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
- 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.
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.
Pilling Weck's Dexterity® Pneumo Sleeve and Protector® Retractor; Karl Storz Endoscopy America, Inc.'s trocars and cannulas for endoscopic and laparoscopic procedures; Solos Endoscopy Inc. GS-4300 Cannula and Trocar and GS-4500 Cannula and Trocar; Marlow Surgical Technologies Hasson SAC Cannula; Ethicon, Inc.'s Endopath Trocar; Innerdyne Medical 'Step' Radical Expansion Obturator/Cannula.
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
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: 011-353-1-295-0744 Facsimile: 011-353-1-294-3319
Contact Person:
Jonathan S. Kahan Hogan & Hartson 555 13th Street, N.W. Washington, DC 20004
(202) 637-5794 Phone: Facsimile: (202) 637-5910
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
1
Classification Name:
Endoscopic Accessory - Extended Laparoscopy Device
Product Code: GCJ
Predicate Devices:
-
- Pilling Weck's Dexterity® Pneumo Sleeve and Protector® Retractor;
-
- Karl Storz Endoscopy America, Inc.'s trocars and cannulas for endoscopic and laparoscopic procedures;
-
- Solos Endoscopy Inc. GS-4300 Cannula and Trocar and GS-4500 Cannula and Trocar:
-
- Marlow Surgical Technologies Hasson SAC Cannula;
-
- Ethicon, Inc.'s Endopath Trocar; and
-
- 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
2
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.
3
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
4
- 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.
5
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.
6
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 (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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
7
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)