PROTECTOR RETRACTOR & PROTECTOR RETRACTOR WITH DRAPE

K954824 · Medical Creative Technologies, Inc. · KKX · Apr 23, 1996 · General, Plastic Surgery

Device Facts

• Record ID: K954824
• Device Name: PROTECTOR RETRACTOR & PROTECTOR RETRACTOR WITH DRAPE
• Applicant: Medical Creative Technologies, Inc.
• Product Code: KKX · General, Plastic Surgery
• Decision Date: Apr 23, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4370
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Sterile, disposable abdominal wound retractor; consists of open-ended cylinder with flexible o-ring at each end; optional integral drape. Device functions by inserting one o-ring into peritoneal cavity and rolling the external o-ring against skin to line wound, prevent contamination, and maintain incision opening. Used in surgical settings by physicians. Replaces combined use of separate wound edge protector drapes and stainless steel self-retaining retractors. Simplifies surgical field by eliminating bulky metal retractor assemblies.

Clinical Evidence

Bench testing on simulated abdominal wall and pig studies verified wound protection and retraction capabilities. Clinical evidence includes a pilot study (n=41) and ongoing pivotal clinical study as part of the DEXTERITY® Pneumo Sleeve system. Results indicate safe and effective performance for wound protection and retraction across four available sizes.

Technological Characteristics

Sterile, single-use disposable device. Construction: flexible o-rings and cylinder (material type unspecified). Form factor: four sizes to accommodate varying incision dimensions. No energy source, software, or connectivity.

Indications for Use

Indicated for patients undergoing abdominal surgery requiring incision protection and retraction.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Wound edge protector drape
• Self-retaining retractor

Reference Devices

• DEXTERITY® Pneumo Sleeve

Submission Summary (Full Text)

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medical creative technologies, inc.
K954824
EXHIBIT 3
K954824
APR 23 1996

510(k) SUMMARY

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

Trade Name: PROTECTOR® Retractor and
PROTECTOR® Retractor with Drape

Common Name: PROTECTOR® Retractor

Classification Name: Protector, Wound, Plastic

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

2950-N Advance Lane • Colmar, PA 18915-9727 • [phone] • FAX [phone]

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K954824

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).