(36 days)
Not Found
No
The device description and performance studies focus on mechanical components and their physical function, with no mention of data processing, algorithms, or learning capabilities.
No
Explanation: The device is described as providing abdominal access, preserving pneumoperitoneum, and protecting incisions during surgery. Its function is to facilitate the surgical procedure and protect the wound, not to directly treat or diagnose a disease or condition.
No
The device description and intended use clearly state that it is for providing abdominal access for a surgeon's hand during laparoscopic surgery, maintaining pneumoperitoneum, and retracting/protecting incisions. These are all surgical functions, not diagnostic ones.
No
The device description clearly outlines physical, sterile, disposable components (Sleeve, Retractor) and the performance studies focus on bench testing and animal/clinical trials involving these physical components. There is no mention of software as a component or function of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide abdominal access and maintain pneumoperitoneum during laparoscopic surgery, and to provide incision retraction and protection during surgery. This is a surgical device used in vivo (on a living patient) during a procedure.
- Device Description: The description details physical components (sleeve, retractor, adhesive flange, velcro strap, flexible rings) designed for physical interaction with the patient's body during surgery.
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens (blood, tissue, etc.) in vitro to provide diagnostic information about a patient's health.
- Performance Studies: The performance studies focus on the functional performance of the device during surgery (bench testing, animal testing, clinical studies evaluating surgical outcomes like procedure time, conversion rates, etc.). There are no studies related to diagnostic accuracy or the analysis of biological samples.
IVD devices are specifically designed to perform tests on samples taken 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 Dexterity® Pneumo Sleeve is intended to provide abdominal access for the surgeon's hand while preserving pneumoperitoneum during laparoscopic surgery.
The Protector® Retractor is intended to provide incision retraction and to protect it against wound contamination during both laparoscopic and open surgery.
This device allows the surgeon to use his hand while performing corrective surgery in the abdominal cavity under pneumoperitoneum.
Product codes
Not Found
Device Description
The Dexterity® Pneumo Sleeve is a sterile, disposable device. It prevents leakage of CO2 and provides an extension of the pneumoperitoneum. It has an adhesive flange at one end that is placed over the inoision and adhered to the patient's abdomen. A velcro strap at the other end is used to tighten the Sleeve around the surgeon's arm.
The Protector® Retractor is a sterile, disposable device. The Retractor consists of an open-ended cylinder with a flexible ring at each end. One ring is inserted through the incision into the peritoneal cavity while the other remains outside the incision. The Retractor holds the incision open and protects it against wound contamination .
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon
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
An initial pilot study involving ten surgeons and forty patients validated the operating principles of the device and allowed surgeons to gain additional device experience. As a result of this original study, minor device changes were implemented in the device design.
A second, pivotal clinical study comparing extended laparoscopic surgery using the Dexterity® Pneumo Sleeve and Protector® Retractor with routine laparoscopic surgery for colon resections, was conducted at 10 clinical centers in the United States and Europe.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical Test Results:
Bench testing was performed on each component of the Dexterity® Pneumo Sleeve and Protector® Retractor to assure that they would function as intended during use.
Based on the data collected in the bench testing, it was concluded that all of the materials were proper for their intended use.
Animal Test Results:
Functional testing on pigs:
Several studies were accomplished using pigs to further verify the function of the device and its components. The results of these studies were effective in fine-tuning the design and working out surgeons' preferences.
Clinical Results:
Two clinical studies were conducted with the Dexterity® Pneumo Sleeve. An initial pilot study involving ten surgeons and forty patients validated the operating principles of the device and allowed surgeons to gain additional device experience. As a result of this original study, minor device changes were implemented in the device design.
A second, pivotal clinical study comparing extended laparoscopic surgery using the Dexterity® Pneumo Sleeve and Protector® Retractor with routine laparoscopic surgery for colon resections, was conducted at 10 clinical centers in the United States and Europe. Safety and effectiveness endpoints considered in this trial included: overall procedure time, number of instrument changes required, conversion rates, i.e., the number of times a case could not be completed laparoscopically and had to be converted to an open procedure, direct operation costs, time for patients to return to normal activity, morbidity and mortality. The results of this prospective, randomized, controlled trial confirmed the safety and effectiveness of the Dexterity® Pneumo Sleeve Set for its intended use as an adjunct to laparoscopic surgery.
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.
Trocar/Cannula by Storz, K954824
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
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
APPENDIX H
510(k) SUMMARY
This summary is organized per 21 CFR 807.92.
Medical Creative Technologies, Inc. 2950-N Advance Lane Colmar, PA 18915
Telephone Number: 215-997-9689 Fax Number: 215-997-2371
Name of Contact: Perk Crook
Date Summary Prepared: April 3, 1996
Name of Device:
Trade Name: Dexterity® Pneumo Sleeve and Protector® Retractor
Common Name: Extended Laparoscopy Device
Classification Name: Extended Laparoscopy Device
Identification of Predicate or Legally Marketed Device(s):
-
- Trocar/Cannula by Storz
-
- Protector Retractor by Medical Creative Technologies, Inc.
The Dexterity® Pneumo Sleeve and Protector® Retractor are substantially equivalent to a Trocar/Cannula from an access to the peritoneal cavity standpoint. Both devices allow access to the peritoneal cavity while preventing CO2 leakage during insertion and withdrawal of instruments. In the case of the Trocar/Cannula, the instruments are laparoscopic instruments and in the case of
1
the Dexterity® Pneumo Sleeve and Protector® Retractor, the instrument is the surgeon's hand. The Trocar/Cannula protects the wound as does the Protector® Retractor from trauma and/or cross-contamination.
The Protector® Retractor which is a component of this device is the same device as the Protector® Retractor (second predicate device named above) approved by 510(k) Number K954824. The Dexterity® Pneumo Sleeve is made from the same 3 mil thick plastic film used to make the sleeve of the Protector® Retractor.
Description of the Device:
The Dexterity® Pneumo Sleeve is a sterile, disposable device. It prevents leakage of CO2 and provides an extension of the pneumoperitoneum. It has an adhesive flange at one end that is placed over the inoision and adhered to the patient's abdomen. A velcro strap at the other end is used to tighten the Sleeve around the surgeon's arm.
The Protector® Retractor is a sterile, disposable device. The Retractor consists of an open-ended cylinder with a flexible ring at each end. One ring is inserted through the incision into the peritoneal cavity while the other remains outside the incision. The Retractor holds the incision open and protects it against wound contamination .
Statement of Intended Use:
The Dexterity® Pneumo Sleeve is intended to provide abdominal access for the surgeon's hand while preserving pneumoperitoneum during laparoscopic surgery.
The Protector® Retractor is intended to provide incision retraction and to protect it against wound contamination during both laparoscopic and open surgery.
This device allows the surgeon to use his hand while performing corrective surgery in the abdominal cavity under pneumoperitoneum.
Summary of Technical Characteristics of this Device Compared to the Predicate Device:
The Dexterity® Pneumo Sleeve and Protector® Retractor are technically the same as the Trocar/Cannula (one of the predicate devices) in that the Trocar/Cannula
2
allows access to the abdominal cavity for laparoscopic instruments and the Dexterity® Pneumo Sleeve and Protector® Retractor allow access to the abdominal cavity for the surgeon's hand. The Trocar/Cannula is made out of stainless steel or plastic while the Dexterity® Pneumo Sleeve and Protector® Retractor are made out of a plastic film, flexible plastic and an acrylate adhesive.
The Protector® Retractor component of the Dexterity® Pneumo Sleeve and Protector® Retractor is the "Protector® Retractor" shown as the second predicate device above. The material making up the sleeve of the Protector® Retractor is the same material as used to make the Dexterity® Pneumo Sleeve.
Summary of Performance Data:
Non-clinical Test Results:
Bench testing was performed on each component of the Dexterity® Pneumo Sleeve and Protector® Retractor to assure that they would function as intended during use.
Based on the data collected in the bench testing, it was concluded that all of the materials were proper for their intended use.
Animal Test Results:
Functional testing on pigs:
Several studies were accomplished using pigs to further verify the function of the device and its components. The results of these studies were effective in fine-tuning the design and working out surgeons' preferences.
Clinical Results:
Two clinical studies were conducted with the Dexterity® Pneumo Sleeve. An initial pilot study involving ten surgeons and forty patients validated the operating principles of the device and allowed surgeons to gain additional device experience. As a result of this original study, minor device changes were implemented in the device design.
3
A second, pivotal clinical study comparing extended laparoscopic surgery using the Dexterity® Pneumo Sleeve and Protector® Retractor with routine laparoscopic surgery for colon resections, was conducted at 10 clinical centers in the United States and Europe. Safety and effectiveness endpoints considered in this trial included: overall procedure time, number of instrument changes required, conversion rates, i.e., the number of times a case could not be completed laparoscopically and had to be converted to an open procedure, direct operation costs, time for patients to return to normal activity, morbidity and mortality. The results of this prospective, randomized, controlled trial confirmed the safety and effectiveness of the Dexterity® Pneumo Sleeve Set for its intended use as an adjunct to laparoscopic surgery.