RENU MEDICAL REPORCESSED COMPRESSIBLE LIMB SLEEVES

K031559 · Renu Medical, Inc. · JOW · Nov 12, 2003 · Cardiovascular

Device Facts

• Record ID: K031559
• Device Name: RENU MEDICAL REPORCESSED COMPRESSIBLE LIMB SLEEVES
• Applicant: Renu Medical, Inc.
• Product Code: JOW · Cardiovascular
• Decision Date: Nov 12, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Hygia West Reprocessed Compression Garments are designed for the prevention of deep vein thrombosis (DVT) as well as the treatment of edema secondary to venous insufficiency. The devices are used in both the home and institutional settings.

Device Story

Reprocessed intermittent pneumatic compression garments; used on foot, calf, or thigh. Input: ambient air from external controller; output: cyclical compression of limb to eject venous blood. Used in home or institutional settings; operated by patients or healthcare providers. Device connects to approved, functional, and correctly adjusted external controller; controller dictates inflation/deflation sequence, pressure, and timing. Reprocessing involves chemical-free high-level disinfection to enable multi-patient use of originally single-patient devices. Benefits include DVT prevention and edema treatment via improved venous return.

Clinical Evidence

No clinical data. Evidence consists of comparative bench testing assessing compression, pressure capabilities, and operational parameters, and biocompatibility testing (NTH level combination irritation/sensitization human skin patch test) to ensure disinfection process safety. Results indicated substantial equivalence to predicate devices.

Technological Characteristics

Intermittent pneumatic compression garments; materials common to medical industry; hook-and-loop or slip-on fastening. Energy source: external pneumatic controller (not reprocessed). Operation: cyclical inflation/deflation of bladders. Sterilization: chemical-free high-level disinfection process.

Indications for Use

Indicated for prevention of deep vein thrombosis (DVT) and pulmonary embolism, and for intra-operative compression therapy. Contraindicated in patients with local leg conditions (dermatitis, gangrene, recent skin grafts, untreated infected wounds), congestive heart failure, severe arteriosclerosis or ischemic vascular disease, pulmonary edema, and known or suspected DVT or phlebitis.

Regulatory Classification

Identification

A compressible limb sleeve is a device that is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb.

Predicate Devices

• Novamedix ImPad A-V Impulse System Rigid Sole Foot Cover
• Hygia Health Services Reprocessed Novamedix ImPad (K021509)
• Huntleigh DVT Compression Sleeves
• Hygia Health Services Reprocessed Huntleigh DVT (K012654)
• Huntleigh Foot Wrap
• Hygia Health Services Reprocessed Huntleigh Foot Wrap (K012651)
• NuTech Calf Wrap
• Hygia Health Services Reprocessed NuTech Calf Wrap (K012657)
• NuTech Combo
• Hygia Health Services Reprocessed NuTech Combo (K012956)
• NuTech Plexipulse System
• Hygia Health Services Reprocessed NuTech Plexipulse (K012650)
• Kendall SCD
• Hygia Health Services Reprocessed Kendall SCD (K012417)
• Microtek Medical Venodyne Sleeve

Submission Summary (Full Text)

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# Ko31559

Image /page/0/Picture/1 description: The image shows the logo for Hygia West Medical Device Reprocessor. The logo features the words "Hygia West" in a bold, sans-serif font, with the words "Medical Device Reprocessor" in a smaller font below. To the left of the words is a graphic of three curved lines above three straight lines.

# 510(k) Summary

# Summary

ı • '

Substantial Equivalence Summary for Hygia West Reprocessed Compression Garments.

In accordance with 21 CFR Part 807.92, this summary is submitted by:

Geolf M. Fatzinger

and

Hygia West, Inc. 9800 Evergreen Way Everett, Washington 98204

Dato: May 13, 2003

#### 1. Contact Person

Geoff M. Fatzinger Director of Compliance and Regulatory Affairs Hygia West Corporate Office 425-353-1110

- 2. Name of Device
Classification Name: Compressible Limb Sleeve Common or Usual Name: Intermittent Pneumatic Compressible Limb Sleeve Review Panel: Cardiovascular Classification: Class II Proprietary Names: Hygia West Reprocessed Novamedix ImPad Hygia West Reprocessed Huntleigh DVT Hygia West Reprocessed Huntleigh Foot Wrap Hygia West Reprocessed Kendall SCD

### Hygia West

9800 Evergreen Way ● Everett, WA. 98204 VOICE 425-353-1110 ● FAX [phone]

.JuI [60] [60] Inc.

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Proprietary Names (cont): Hygia West Reprocessed NuTech Plexipulse Hygia West Reprocessed NuTech Combo Hygia West Reprocessed NuTech Calf Wrap Hygia West Reprocessed Venodyne

## Predicate Devices

3.

:

| Classification Name: | Compressible Limb Sleeve |
|----------------------|-----------------------------------------------------------|
| Common Name: | Intermittent Pneumatic Compressible Limb Sleeve |
| Classification: | Class II |
| Proprietary Name: | Novamedix ImPad® A-V Impulse System Rigid Sole Foot Cover |
| Classification Name: | Compressible Limb Sleeve |
| Common Name: | Intermittent Pneumatic Compressible Limb Sleeve |
| Classification: | Class II |
| Proprietary Name: | Hygia Health Services Reprocessed Novamedix ImPad® |
| 510(k) number: | K021509 |
| Classification Name: | Compressible Limb Sleeve |
| Common Name: | Intermittent Pneumatic Compressible Limb Sleeve |
| Classification: | Class II |
| Proprietary Name: | Huntleigh DVT Compression Sleeves |
| Classification Name: | Compressible Limb Sleeve |
| Common Name: | Intermittent Pneumatic Compressible Limb Sleeve |
| Classification: | Class II |
| Proprietary Name: | Hygia Health Services Reprocessed Huntleigh DVT |
| 510(k) number: | K012654 |
| Classification Name: | Compressible Limb Sleeve |
| Common Name: | Intermittent Pneumatic Compressible Limb Sleeve |
| Classification: | Class II |
| Proprietary Name: | Huntleigh Foot Wrap |
| Classification Name: | Compressible Limb Sleeve |
| Common Name: | Intermittent Pneumatic Compressible Limb Sleeve |
| Classification: | Class II |
| Proprietary Name: | Hygia Health Services Reprocessed Huntleigh Foot Wrap |
| 510(k) number: | K012651 |

### Hygia West

9800 Evergreen Way · Everett, WA. 98204 VOICE 425-353-1110 ● ● FAX [phone]

. . . . . . . . . . .

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Predicate Devices (cont):

Classification Name: Compressible Limb Sleeve Intermittent Pneumatic Compressible Limb Sleeve Common Name: Class II Classification: NuTech Calf Wrap Proprietary Name:

Classification Name: Compressible Limb Sleeve Intermittent Pneumatic Compressible Limb Sleeve Common Name: Class II Classification: Hygia Health Services Reprocessed NuTech Calf Wrap Proprietary Name: K012657 510(k) number:

Classification Name: Compressible Limb Sleeve Intermittent Pneumatic Compressible Limb Sleeve Common Name: Classification: Class II Proprietary Name: NuTech Combo

Classification Name: Compressible Limb Sleeve Intermittent Pneumatic Compressible Limb Sleeve Common Namc: Classification: Class II Hygia Health Services Reprocessed NuTech Combo Proprietary Name: S10(k) number: K012956

Classification Name: Compressible Limb Sleeve Intermittent Pneumatic Compressible Limb Sleeve Common Name: Classification: Class II NuTech Plexipulse System Proprietary Name:

Classification Name: Compressible Limb Sleeve Intermittent Pneumatic Compressible Limb Sleeve Common Name: Class II Classification: Hygia Health Services Reprocessed NuTech Plexipulse Proprietary Name: 510(k) number: K0126S0

Classification Name: Compressible Limb Sleeve Intermittent Pneumatic Compressible Limb Sleeve Common Name: Class II Classification: Kendall SCD Proprietary Name:

### Hygia West

9800 Evergreen Way · Everett, WA. 98204 VOICE 425-353-1110 ● FAX [phone]

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Predicate Devices (cont):

| | Classification Name: Compressible Limb Sleeve |
|-------------------|-------------------------------------------------|
| Common Name: | Intermittent Pneumatic Compressible Limb Sleeve |
| Classification: | Class II |
| Proprietary Name: | Hygia Health Services Reprocessed Kendall SCD |
| 510(k) number: | K012417 |

Classification Name: Compressible Limb Sleeve Intermittent Pneumatic Compressible Limb Sleeve Common Name: Classification: Class II Microtek Medical Venodyne Slecve Proprietary Name:

### Statement of Substantial Equivalence

The Hygia West Reprocessed Compression Garments employ no new technology other than the method used to reprocess the garment in order to allow the device to be utilized more than once. The Hygia West Reprocessed Compression Garments are substantially equivalent to the listed predicate devices in that the basis of operation of the devices is the intermittent inflation of a bladder or chamber, which is placed around the patient's lower limb. The devices are used on the calf, thigh, whole leg, or foot. The garments are then connected to an approved and device appropriate controller. Inflation of the device is accomplished using ambicnt air, and a controller cycle that functions to alternately inflate and deflate the device in a predetermined manner and interval.

The Hygia West Reprocessed Compression Garments are substantially equivalent in function, operating parameters, and intended use to the listed predicate devices that are currently commercially available and in distribution. The predicate devices are marked for "single-patient use only" as are the Hygia West devices. Hygia West does not change the devices in any way except to render the device "reusable" by placing it through a scientifically verified chemical free high-level disinfection process. The Hygia West high-level disinfection protocol does not alter the device's efficacy, safety, composition, or intended use. Hygia West employs very strict device protocols, unique and stringent testing procedures, innovative, and demanding quality measures that in many cases exceed those of the predicate device companies. Although our processes are very different, the core concept regarding the high-level disinfection process is identical to the method used by Hygia Health Services, Inc in their approved reprocessed devices.

> Hygia West 9800 Evergreen Way · Everett, WA. 98204 VOICE 425-353-1110 ● FAX [phone]

Relu Nedical Inc.

. . . .

4.

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#### న్. Description of the Devices

The Llygia West Reprocessed Compression Garments are intermittent compressible limb devices that are placed around cither the patient's foot (with the compression chamber placed under the plantar arch), calf (gastrocnemius muscle), thigh, or a combination there of. The garments are constructed from materials that are common to the medical device industry. Depending on the type of device, the method of fastening to the patient may vary from a hook and loop closure system to a uni-body style that is slipped over the limb. In foot compression devices, as the garment compresses the plantar plexus, the veins collapse longitudinally; this action causes an increase in the venous pressure thus eiceting the blood upward. After compression, the devices deflate allowing the veins to refill bringing oxygenared blood to the lower limbs. In devices used on the calf or thigh the compression to the area causes the blood to be ejected upwards to the heart, as the compression relaxes the valves in the veins close allowing them to refill. This cyclical method removes deoxygenated or stale blood from the region allowing fresh blood to be received. On all devices the controller predetermines the inflation and deflation sequence. The operational characteristics such as the pressure of compression, hold time, and inflation time are determined by the controller. It is the responsibility of the end user to ensure that the device is connected to an approved controller and to ensure that the controller settings are accurate. Hygia West does not repair, refurhish, or reprocess the controlling unit. Hygia West guarantees 100% of our devices ONLY if it has heen connected to an approved, functional, and correctly adjusted controller.

Hygia West has included a device specific summary including relevant comparisons in each individual device section. (Please see tab marked "Summary" in each chapter)

#### ર્. Intended Use of Device

The Hygia West Reprocessed Compression Garments operate in the identical manner as the predicate devices. They are designed for the prevention of deep vein thrombosis (DVT) as well as the treatment of edema secondary to venous insulficiency. The devices are used in both the home and institutional settings.

#### 7. Technological Characteristics

The technological characteristics of the Hygia West Reprocessed Compression Garments are identical to the predicate devices in overall design, materials, energy source, mode of operation, and performance characteristics.

> Hygia West 9800 Evergreen Way ● Everett, WA. 98204 VOICE 425-353-1110 ● FAX [phone]

. . .

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#### 8. Performance Data

Non-clinical Tests- Comparative bench testing was utilized to assess and prove similarity of function between the Hygia West Reprocessed Compression Garments and the predicate devices. All tests found that functional and operational performance characteristics including compression, pressure capabilities, safety, and operational parameters were substantially equivalent.

#### છે. Biocompatibility

...

In order to ensure that the high-level disinfection program does not adversely affect the biocompatibility of the device, a NTH level combination irritation/sensitization human skin patch test was conducted. The detailed protocols of the study are included for each device in that specific device section. No signs of irritation or sensitization were found.

#### 10. Process Validation

Process validation information has been provided as part of this submission to demonstrate the effectiveness of this type of technology,

#### l l . Conclusions

Test Conclusions- Non-clinical and biocompatibility test results indicated substantial equivalence in all aspects to the predicate devices.

> Hygia West 9800 Evergreen Way · Everett, WA. 98204 VOICE 425-353-1110 ● FAX [phone]

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Public Health Service

Image /page/6/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with stylized wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# NOV 1 2 2003

ReNu Medical c/o Mr. Geoff M. Fatzinger Director of Compliance and Regulatory Affairs 9800 Evergreen Way Everett, WA 98204

Re: K031559

Trade Name: ReNu Medical Reprocessed Compressible Limb Sleeves Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II (two) Product Code: JOW Dated: May 13, 2003 Received: May 29, 2003

Dear Mr. Fatzinger:

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 (PMA), 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

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Page 2 – Mr. Geoff M. Fatzinger

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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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,

Image /page/7/Picture/4 description: The image shows a signature. The signature is in black ink and appears to be cursive. The signature is illegible, but it appears to start with the letter 'f' or 'p'. The signature is on a white background.

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# INDICATIONS FOR USE

Applicant: Hygia West, Inc.

KO 31259 510(k) Number:

Device Name: Hygia West Reprocessed Huntleigh DVT Sleeve

Indications For Use:

The Hygia West Reprocessed Huntleigh DVT Sleeve is to be used by patients in both the home and institutional settings used as a non-invasive therapeutic method to:

- Prevent deep vein thrombosis and resulting pulmonary embolism .
- Intra-operative compression therapy ●

# PRECAUTIONS AND CONTRAINDICATIONS

Contraindications:

Sleeves may not be recommended for patients with the following:

- Any local leg condition in which sleeves would interfere such as 1. dermatitis, gangrene, recent skin graft, untreated infected wounds.
- 2. Congestive heart failure.
- Severe arteriosclerosis or other ischemic vascular disease 3.
- Pulmonary edema 4.
- ર : Known or suspected deep vein thrombosis or phlebitis

Qias Moli

ardiovascular Devices

**510(k) Number** k031559
p. 1/2

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### Indications for Use

Precautions:

- 1. One must ensure that the sleeve is applied properly.
- 2. One must ensure that the sleeve is correctly connected to the pump and that the connection is secure.
- If numbness, tingling, or leg pain is experienced by the patient, the sleeve 3. should be removed.

Elias Mdaa

(Division Sign-C Division of Cardiovascular Devices

K031559 510(k) Number p. 212

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