(186 days)
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No
The description focuses on a mechanical device for wound protection and retraction, with no mention of AI/ML terms, image processing, or data-driven performance metrics.
No.
The device is used to protect and retract an incision during surgery, not to treat a disease or condition.
No
Explanation: The device description states its purpose is to protect and retract an incision in the abdominal wall, which is a therapeutic and protective function, not a diagnostic one.
No
The device description clearly states it is a sterile, disposable device consisting of an open-ended cylinder with flexible o-rings, indicating it is a physical hardware 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 "protect and retract an incision in the abdominal wall." This is a surgical device used directly on a patient's body during a procedure.
- Device Description: The description details a physical device (cylinder with o-rings) used for surgical manipulation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside or on the body) during surgery.
N/A
Intended Use / Indications for Use
This device is to be used to protect and retract an incision in the abdominal wall. This is accomplished by placing one o-ring through the incision into the peritoneum cavity while the other o-ring remains outside of the incision. The outside o-ring is then rolled down against the skin. This lines the wound to protect against contamination and holds the incision open.
Product codes
79EYS
Device Description
The PROTECTOR® Retractor is a sterile, disposable device. The PROTECTOR® Retractor consists of an open-ended cylinder with a flexible o-ring at each end. The PROTECTOR® Retractor with a drape is the same configuration, except that it has a drape that is an integral part of it.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
abdominal wall
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
The PROTECTOR® Retractor was lab tested on a fake abdominal wall and in pig studies to verify that it could protect the wound at the same time as retracting the wound (holding it open). Both PROTECTOR® Retractor and the two predicate devices accomplished the same thing, except that the PROTECTOR® Retractor is much simpler to use and keeps the operating area clear of any contraptions.
The PROTECTOR® Retractor is a component of the DEXTERITY® Pneumo Sleeve and PROTECTOR® Retractor which has been through a pilot clinical and is presently in a pivotal clinical. The results of the pilot clinical (41 subject) and the pivotal clinical to date is that the PROTECTOR® Retractor works safely and effectively to protect the wound and hold it open.
Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 878.4370 Surgical drape and drape accessories.
(a)
Identification. A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The device includes a plastic wound protector that may adhere to the skin around a surgical incision or be placed in a wound to cover its exposed edges, and a latex drape with a self-retaining finger cot that is intended to allow repeated insertion of the surgeon's finger into the rectum during performance of a transurethral prostatectomy.(b)
Classification. Class II (special controls). The device, when it is an ear, nose, and throat surgical drape, a latex sheet drape with self-retaining finger cot, a disposable urological drape, a Kelly pad, an ophthalmic patient drape, an ophthalmic microscope drape, an internal drape retention ring (wound protector), or a surgical drape that does not include an antimicrobial agent, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.
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Image /page/0/Picture/1 description: The image shows the logo for Medical Creative Technologies, Inc. The logo consists of the letters "CT" in a bold, stylized font, with the word "medical" above the letters. To the right of the letters is the text "medical creative technologies, inc." The text is in a smaller font than the letters "CT".
EXHIBIT 3
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510(k) SUMMARY
PR 23 1996
Medical Creative Technologies, Inc. 2950-N Advance Lane Colmar. PA 18915
215-997-9689 215-997-2371 (FAX)
Name of Contact Person: Perk Crook
October 20, 1995 Revised March 22, 1996
PROTECTOR® Retractor and Trade Name: PROTECTOR® Retractor with Drape
PROTECTOR® Retractor Common Name:
Protector, Wound, Plastic Classification Name:
Classification Number: 79EYS
The legally marketed devices to which we are claiming equivalency are a wound edge protector drape and a self-retaining retractor.
Description of the Device:
The PROTECTOR® Retractor is a sterile, disposable device. The PROTECTOR® Retractor consists of an open-ended cylinder with a flexible o-ring at each end. The PROTECTOR® Retractor with a drape is the same configuration, except that it has a drape that is an integral part of it.
Intended Use of the Device:
This device is to be used to protect and retract an incision in the abdominal wall. This is accomplished by placing one o-ring through the incision into the peritoneum cavity while the other o-ring remains outside of the incision. The outside o-ring is then rolled down against the skin. This lines the wound to protect against contamination and holds the incision open.
Developers of innovative medical devices
1
Summary of Technical Characteristics of this Device Compared to the Predicate Device:
The PROTECTOR® Retractor accomplishes what the "Wound Edge Protector Drape" and "Self-Retaining Retractors" accomplish, except that it is one device rather than two. The "Wound Edge Protector Drape" is made out of the same type of material as the PROTECTOR® Retractor, whereas the "Self-Retaining Retractor" is made out of stainless steel and is an assembly of various angled irons, rods, clamps and screws. The PROTECTOR® Retractor accomplishes the same thing as the "Wound Edge Protector Drape" and "Self-Retaining Retractor" used in concert. The PROTECTOR® Retractor is a single-use disposable device as is the "Wound Edge Protector Drape", whereas the "Self-Retaining Retractor" is re-usable.
Assessment of Performance Data:
The PROTECTOR® Retractor was lab tested on a fake abdominal wall and in pig studies to verify that it could protect the wound at the same time as retracting the wound (holding it open). Both PROTECTOR® Retractor and the two predicate devices accomplished the same thing, except that the PROTECTOR® Retractor is much simpler to use and keeps the operating area clear of any contraptions.
Assessment of Performance Data- Clinical:
The PROTECTOR® Retractor is a component of the DEXTERITY® Pneumo Sleeve and PROTECTOR® Retractor which has been through a pilot clinical and is presently in a pivotal clinical. The results of the pilot clinical (41 subject) and the pivotal clinical to date is that the PROTECTOR® Retractor works safely and effectively to protect the wound and hold it open. The PROTECTOR® Retractor will be available in four different sizes which will accommodate different size incisions depending on the abdominal surgery being undertaken.
Conclusion Drawn from the Non-Clinical and Clinical Data:
It is concluded that the PROTECTOR® Retractor with or without Drape is as safe and effective as the two predicate devices from the standpoint of toxicology, protection of the wound and the physical retraction of the wound.
This concludes the summary for this 510(k).