EQUIPMENT COVERS

K961699 · United States Surgical, A Division of Tyco Healthc · MMP · Aug 23, 1996 · General, Plastic Surgery

Device Facts

• Record ID: K961699
• Device Name: EQUIPMENT COVERS
• Applicant: United States Surgical, A Division of Tyco Healthc
• Product Code: MMP · General, Plastic Surgery
• Decision Date: Aug 23, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4370
• Device Class: Class 2

Intended Use

Both the Auto Suture* Equipment Covers** and the Sterile Equipment Covers by Custom Medical Products (K931417) are intended to cover equipment and are not intended to be as patient drapes or have patient contact.

Device Story

Polyethylene covers in various sizes/shapes; positioned over surgical equipment to maintain sterile field and facilitate cleanup. Used in surgical settings by clinical staff. Provides fluid barrier; resistant to puncture and tearing. Benefits include equipment protection and simplified post-operative sanitation.

Clinical Evidence

Bench testing only. Evaluation of tear resistance, puncture resistance, fluid penetration resistance, and material thickness demonstrated acceptable performance as a fluid barrier.

Technological Characteristics

Polyethylene material; compliant with ISO Standard #10993-1. Form factor: various sizes/shapes of equipment covers. Non-powered, mechanical barrier.

Indications for Use

Indicated for covering surgical equipment to maintain a sterile field and assist in post-surgical cleanup. Not for use as patient drapes; no patient contact intended.

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

• Sterile Equipment Covers by Custom Medical Products (K931417)

Submission Summary (Full Text)

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13/08/96 14:26 NO. 315 004
K961699

**Attachment I**

**510(k) SUMMARY OF INFORMATION:**

**SUBMITTER:** United States Surgical Corporation
150 Glover Avenue
Norwalk, CT 06856
[phone]

**CONTACT PERSON:** Janet G. Johnson

**DATE PREPARED:** June 28, 1996

**CLASSIFICATION NAME:** Equipment Covers

**COMMON NAME:** Equipment Covers

**PROPRIETARY NAME:** Auto Suture* ABBI* System Equipment Cover

**PREDICATE DEVICE:** Sterile Equipment Covers by Custom Medical Products (K931417)

**DEVICE DESCRIPTION:** Both the Auto Suture* Equipment Covers** and the Sterile Equipment Covers by Custom Medical Products (K931417) consist of various sizes and shapes of polyethylene covers which are positioned on surgical equipment. The covers are used to maintain the surgeons sterile field and as an aid in the clean up of equipment after surgery.

**INTENDED USE:** Both the Auto Suture* Equipment Covers** and the Sterile Equipment Covers by Custom Medical Products (K931417) are intended to cover equipment and are not intended to be as patient drapes or have patient contact.

**MATERIALS:** All component materials of the Auto Suture* Equipment Covers** are comprised of materials which are in accordance with ISO Standard #10993-1.

**PERFORMANCE:** A study was done to test the performance of the Auto Suture* Equipment Covers**. Testing consisted of an evaluation of tear resistance, puncture resistance, fluid penetration resistance and material thickness. Testing results, demonstrate that the Auto Suture* Equipment Covers** provides an acceptable fluid barrier which is resistant to puncturing, tearing and fluid penetration under normal use conditions.