APPLE MEDICAL/OB MOBIUS ELASTIC RETRACTOR

K050256 · Apple Medical Corp. · GAD · Apr 26, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K050256
• Device Name: APPLE MEDICAL/OB MOBIUS ELASTIC RETRACTOR
• Applicant: Apple Medical Corp.
• Product Code: GAD · General, Plastic Surgery
• Decision Date: Apr 26, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4800
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The Apple Medical OB/Mobius Elastic Retractor is indicated for use to assist in nonurgent cesarean deliveries that are routine procedures. It is intended to provide incision retraction and to protect against wound contamination during a cesarean section. It is indicated for use as a surgical retractor for both vertical and transverse incisions.

Device Story

Sterile, disposable abdominal retractor; consists of two flexible plastic rings connected by a sleeve of high-yield strength, clear plastic film. Internal ring (o-ring) inserted through abdominal incision; external ring (quad-ring) pulled upward to place sleeve in tension. Operator rolls external ring down sleeve to retract abdominal wall via radial force. Used in clinical settings during cesarean sections; operated by surgeons. Provides incision retraction and wound contamination protection; benefits patient by maintaining surgical site access and reducing exposure to wound contaminants.

Clinical Evidence

Clinical evaluation performed for the cesarean section indication; device shown to be substantially equivalent to predicate mechanical abdominal retractors.

Technological Characteristics

Sterile, disposable device. Internal ring: circular cross-section (o-ring). External ring: cruciform cross-section (quad-ring). Sleeve: high-yield strength, clear plastic film. Principle: radial force generated by tensioning the sleeve between the two rings to retract abdominal wall to a circular geometry.

Indications for Use

Indicated for patients undergoing routine, non-urgent cesarean deliveries requiring incision retraction and wound protection; suitable for both vertical and transverse incisions.

Regulatory Classification

Identification

A manual surgical instrument for general use is a nonpowered, hand-held, or hand manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892 of this chapter.

Predicate Devices

• Apple Medical OB/Mobius® Elastic Retractor (K041131)
• 510(k) exempt mechanical abdominal retractors

Submission Summary (Full Text)

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K050256
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## APR 2 6 7005

## 510(k) Summary

| Sponsor | Apple Medical Corporation<br>28 Lord Road, Unit 135<br>Marlboro, MA 01752 |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date of summary | April 20, 2005 |
| Device Trade Name | Apple Medical OB/Mobius® Elastic Retractor (OB/MER) |
| Common Name | Abdominal Retractor |
| Classification Name | Obstetric-gynecologic general manual instrument (884. 4520)<br>Obstetric-gynecologic specialized manual instrument (884.4530)<br>Manual surgical instruments for general use (878.4800) |
| Predicate Devices | The Apple Medical OB/Mobius® Elastic Retractor (K041131) and<br>510(k) exempt mechanical abdominal retractors used in cesarean section. |
| Description | The Apple Medical OB/Mobius® Elastic Retractor is a sterile disposable<br>abdominal retractor consisting of two flexible plastic rings connected by a<br>sleeve of soft, high yield strength, clear plastic film. The internal ring has<br>a circular cross-section (o-ring) and the external ring has a cruciform<br>cross-section (quad-ring). The inner diameter of the internal o-ring limits<br>the radius of abdominal retraction. The diameter of the external quad-ring<br>is the same as the diameter of the internal o-ring and the sleeve. When<br>completely unwound, the height of the cylinder is 10.6 inches. When the<br>quad ring is rolled down, the sleeve is wrapped around the circumference<br>of the ring reducing the height of the sleeve by 1.5 inches per rotation.<br>Because the sleeve film is radially unyielding, the reduction in height<br>causes the radial retraction of the incision site. |
| Intended Use | The Apple Medical OB/Mobius Elastic Retractor is indicated for use to<br>assist in non-urgent cesarean deliveries that are routine procedures. It is<br>intended to provide incision retraction and to protect against wound<br>contamination during a cesarean section. It is indicated for use as a<br>surgical retractor for both vertical and transverse incisions. |
| Technological<br>Characteristics | The internal o-ring is manually collapsed and inserted through the<br>abdominal incision where it is allowed to spring open against the parietal<br>peritoneum. The external quad-ring is then pulled upward placing the<br>cylindrical sleeve in tension and the operator rolls the ring down the<br>sleeve until the ring sits firmly against the skin. The radial force of the<br>two rings acts to retract the abdominal wall to the desired circular<br>geometry. |
| Testing | The Apple Medical OB/Mobius Elastic Retractor has been clinically<br>evaluated for the cesarean section indication and shown to be<br>substantially equivalent to the predicate mechanical abdominal retractors. |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/2 description: The image shows a logo for the Department of Health & Human Services. The logo features a stylized eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged in a circular pattern around the eagle.

APR 2 6 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Apple Medical Corporation c/o Mr. James Delaney Boston Healthcare Associates, Inc. 75 Federal St., 9th Floor BOSTON MA 02110

Re: K050256

Trade/Device Name: Apple Medical OB/Mobius® Elastic Retractor Regulation Number: 21 CFR §884.4530 Regulation Name: Obstetric-gynecologic specialized manual instrument Product Code: KNA Regulation Number: 21 CFR §878.4800 Regulation Name: Manual surgical instrument for general use Product Code: GAD Regulatory Class: II Dated: April 1, 2005 Received: April 4, 2005

Dear Mr. Delaney:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Nancy C. brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K050256

Device Name: Apple Medical OB/Mobius® Elastic Retractor

Indications for Use:

The Apple Medical OB/Mobius Elastic Retractor is indicated for use to assist in nonurgent cesarean deliveries that are routine procedures. It is intended to provide incision retraction and to protect against wound contamination during a cesarean section. It is indicated for use as a surgical retractor for both vertical and transverse incisions.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C Bugdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K050256

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