HI-SLIP AND HI-SLIP PLUS SINGLE USE HYDROPHILIC URINARY CATHETERS AND KIT

K062444 · Oasis Medikal Urunler Kimya Sanayi VE Tic A.S. · EZD · Feb 22, 2007 · Gastroenterology, Urology

Device Facts

• Record ID: K062444
• Device Name: HI-SLIP AND HI-SLIP PLUS SINGLE USE HYDROPHILIC URINARY CATHETERS AND KIT
• Applicant: Oasis Medikal Urunler Kimya Sanayi VE Tic A.S.
• Product Code: EZD · Gastroenterology, Urology
• Decision Date: Feb 22, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5130
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Hi-Slip, Hi-Slip Plus and Hi-Slip Kit are launched for Clean Intermittent Catheterization-CIC treatment and is indicated for use by patients with chronic urine retention. The catheter is inserted into the bladder through the urethra for emptying the bladder.

Device Story

Hi-Slip family consists of single-use, hydrophilic-coated PVC urinary catheters for clean intermittent catheterization (CIC). Input: manual insertion into urethra. Transformation: hydrophilic coating (polyvinyl pyrrolidone) binds water to surface to reduce friction during insertion. Output: bladder drainage. Variants: Hi-Slip (standard), Hi-Slip Plus (includes integrated sterile water sachet for activation), Hi-Slip Kit (includes catheter, water sachet, urine collection bag, povidone iodine swab). Used in clinical or home settings by patients or caregivers. Benefits: reduced urethral friction, simplified catheterization process, sterile drainage. Healthcare providers use output (urine drainage) to manage chronic retention.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993 standards, including acute systemic toxicity (ISO 10993-11), sensitization (ISO 10993-10), genotoxicity (ISO 10993-3), cytotoxicity (ISO 10993-5), and skin irritation (ISO 10993-10). All tests met requirements.

Technological Characteristics

Materials: Medical grade polyvinyl chloride (PVC) catheter coated with hydrophilic polymer (polyvinyl pyrrolidone/PVP). Dimensions: Various lengths (20-40 cm) and French sizes (CH 06-24). Energy source: None (mechanical). Sterilization: Sterile. Connectivity: None. Software: None.

Indications for Use

Indicated for patients with chronic urine retention requiring clean intermittent catheterization to empty the bladder via urethral insertion.

Regulatory Classification

Identification

A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudé catheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).

Predicate Devices

• LoFric Single Use Urinary Catheter (K896750)
• LoFric Plus Single Use Urinary Catheter (K012374)
• SpeediCath (K023254)
• FloaCath Catheter (K000070)
• LoFric Primo Single Use Urinary Catheter (K050874)
• LoFric Plus Hydro-Kit II Single Use Urinary Catheter (K043241)
• EasiCath Set (K973070)

Submission Summary (Full Text)

{0}------------------------------------------------

K062444

pg 1 of 9

# 510(k) SUMMARY

FEB 2 2 2007

#### 3.1. Submitter

Contact Person: Phone number:

Fax number:

Oasis Medikal Ürünler Kimya Sanayi ve Tic.A.S. Yıdızevler Mah. 4. Cad. 82. Sok. Cankaya 06550, ANKARA TURKEY Ayşe Yerlikaya [phone] [phone]

Date of Preparation of the Summary: August 16th, 2006

### 3.2. Device Name

#### A-Device Name-CATHETER

Classification Name: Urological Catheter Urinary Catheter for Intermittent Use Common/Usual Name: Proprietary Name: Hi-Slip

#### B-Device Name-CATHETER

| Classification Name: | Urological Catheter |
|----------------------|---------------------------------------|
| Common/Usual Name: | Urinary Catheter for Intermittent Use |
| Proprietary Name: | Hi-Slip Plus |

# C-Device Name-CATHETER

Classification Name: Common/Usual Name: Proprietary Name:

Urological Catheter Kit Urinary Catheter Kit for Intermittent Use Hi-Slip Kit

# 3.3. Device Classification

Hi-Slip, Hi-Slip Plus and Hi-Slip Kit all have been classified by the FDA under the heading of Urological Catheters and Accessories as a Class II device in accordance with the regulations under 21 CFR 876.5130. Thev are all Prescription Devices meaning they can be sold by or on the offer of a physician.

The appropriate panel is Gastroenterology or Urology and the Product Code is GBM/Catheter,Urethral.

{1}------------------------------------------------

K 062444

J72gg

# 3.4. Device Description

The Hi-Slip Hydrophilic Urinary Catheter is a single use urinary catheter designed for Clean Intermittent Catheterization, drainage of bladder. The device consists of disposable polyvinyl chloride catheter (medical grade PVC) coated with hydrophilic polymer. When the catheter is immersed in water for 30 seconds, it becomes slippery and ready to use. The catheter is provided in a variety of sizes and lengths.

The Hi-Slip Plus Hydrophilic Urinary Catheter is a single use urinary catheter designed for Clean Intermittent Catheterization, drainage of bladder. The device consists of disposable PVC (medical grade) catheter coated with hydrophilic polymer and water sachet (sterile water). Coating is activated by the water of integrated water sachet. Water is let down by squeezing the water sachet. When the catheter is immersed in water for 30 seconds, it becomes slippery and ready to use. The PLUS is provided in a variety of sizes and lengths.

Hi-Slip Kit includes a single use coated PVC (medical arade) catheter, urine bag (medical grade PVC urine bag), water sachet (sterile water) and povidone iodine swab for cleaning urethra outlet prior to catheterization. The catheter is coated with a hydrophilic polymer (polyvynil pyrolidone, PVP) which makes the catheter surface slipperv when dipped into the water. Patient clean the urethra outlet by using povidone iodine swab and lets the water fill the catheter place in the urine bag by squeezing the sachet. When the catheter is immersed in water for 30 seconds, it becomes slippery and ready to use. Patient disposes the urine directly into urine bag. The KIT is provided in a variety of sizes and lenaths.

#### 3.5. Intended Use

Hi-Slip, Hi-Slip Plus and Hi-Slip Kit are all launched for Clean Intermittent Catheterization-CIC treatment and indicated for use by patients with chronic urine refention. The catheter is inserted into the bladder through the urethra for emptying the bladder.

# 3.6. Summary of Technological Characteristics/Statement of Substantial Equivalence:

All predicate catheters are single use and intended for single intermittent catheterization.

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image contains handwritten text. The top line reads "Kob24444". The second line reads "Pg 3 of 9". The text appears to be written in black ink on a white background.

The catheter is pre-lubricated with a coating containing polyvinyl pyrrolidone- a kind of hydrophilic polymer (PVP), which binds the water molecules to the surface of the catheter to reduce the risk of friction while inserting the catheter into the urethra.

Hi-Slip is substantially equivalent to the following predicate devices:

- · LoFric®Single Use Urinary Catheter K896750, Astra Tech Inc.
- LoFric®Plus Single Use Urinary Catheter K012374, Astra Tech Inc. .
- SpeediCath K023254, Coloplast Corp. .
- FloaCath Catheter K000070, Rüsch International. .

Hi-Slip Plus (with water sachet) is substantially equivalent to the following predicate devices:

- · LoFric® Primo Single Use Urinary Catheter K050874, Astra Tech Inc.
- SpeediCath K023254, Coloplast Corp. .

Hi-Slip Kit (with urine bag, water sachet and povidone iodine swab) is substantially equivalent to the following predicate devices:

- · LoFric®Plus Hydro-Kit II Single Use Urinary Catheter K043241, Astra Tech Inc.
- EasiCath Set K973070, Coloplast Corp. Branded as the SureCath Set . in the US.

{3}------------------------------------------------

K062444
Ry489

# 3.7. Substantial Equivalence Comparison:

Boys/Pediatric

30 cm, CH06-10

Girls/Pediatric

20 cm, CH06-10

Tiemann 40 cm,

CH10-18

| Table 3.1.<br>Properties | Hi-Slip-Substantial Equivalence Comparison - General | | | |
|--------------------------|-----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Hi-Slip<br>Hydrophilic<br>Urinary<br>Catheter | LoFric® Single<br>Use Urinary<br>Catheter, Astra<br>Tech Inc. | LoFric® Plus<br>Single Use<br>Urinary Catheter,<br>Astra Tech Inc. | SpeediCath<br>Coloplast<br>Corp. |
| 510 (k)<br>number | | K896750 | K012374 | K023254 |
| Device<br>composition | Polyvinyl<br>chloride (PVC)<br>catheter<br>coated<br>with<br>polyvinylpyr-<br>rolidone. | Polyvinylchloride<br>(PVC) catheter<br>coated with<br>polyvinylpyr-<br>rolidone and<br>salt. | Polyether block<br>amide catheter<br>coated with<br>polyvinyl-<br>pyrrolidone and<br>salt. | Polyurethane<br>catheter<br>coated<br>with<br>polyvinylpyr-<br>rolidone,<br>placed in<br>a saline<br>solution<br>containing<br>polivinyl-<br>pyrrolidone. |
| Sizes | Male 40 cm,<br>CH08-24<br><br>Female 20 cm,<br>CH08-18 | Male 40 cm<br>CH 08-24<br><br>Female 15 cm<br>CH 08-14<br>Female 20 cm | Male 40 cm<br>CH 08-24<br><br>Female 20 cm<br>CH 08-18 | Male 40 cm<br>CH08-18<br><br>Female 20 cm<br>CH 06-16 |

CH 08-18

Pediatric 20 cm

CH06-10

Pediatric 30 cm

CH06-10

Tiemann 40 cm CH 10-18

Pediatric 20 cm

CHOP-10

Pediatric 30 cm

CHO6-10

Tiemann 40 cm

CH 10-18

Pediatric 20

cm

CH 06-10

Tiemann 40

cm

CH 10-14

{4}------------------------------------------------

K062444
pg 5089

| | Hi-Slip<br>Hydrophilic<br>Urinary Catheter | LoFric® Single<br>Use Urinary<br>Catheter, Astra<br>Tech Inc. | LoFric® Plus<br>Single Use Uri-<br>nary Catheter,<br>Astra Tech Inc. | SpeediCath<br>Coloplast<br>Corp. |
|------------------------------|--------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|
| Function of<br>the<br>device | Inserted into the<br>bladder through<br>the urethra for<br>emptying the<br>bladder | Inserted into the<br>bladder through<br>the urethra for<br>emptying the<br>bladder | Inserted into<br>the bladder<br>through the<br>urethra for<br>emptying the<br>bladder | Inserted into<br>the bladder<br>through the<br>urethra for<br>emptying the<br>bladder |
| Indication<br>for use | Intermittent<br>catheterization<br>(Because of<br>chronic urine<br>retention and<br>other voiding<br>dysfunctions. | Intermittent<br>catheterization | Intermittent<br>catheterization | Chronic urine<br>re-<br>tention,<br>post-void<br>residual<br>volume (PVR)<br>and voiding<br>dysfunctions. |
| Features<br>of the<br>device | Hydrophilic<br>coated. Slippery<br>surface. Low<br>friction between<br>catheter and<br>urethral mucosa. | Hydrophilic<br>coated. Low<br>friction between<br>catheter<br>and urethral<br>mucosa. | Hydrophilic<br>coated. Low<br>friction<br>between<br>catheter<br>and urethral<br>mucosa. | Hydrophilic<br>coated.<br>Low friction<br>between<br>catheter and<br>urethral<br>mucosa.<br>Ready to use. |
| Sterility | Sterile | Sterile | Sterile | Sterile |
| Packaging | Peel Pack | Peel Pack | Peel Pack | Peel Pack |

| | | Table 3.2. Hi-Slip-Substantial Equivalence Comparison: Indications for Use |
|--|--|----------------------------------------------------------------------------|
|--|--|----------------------------------------------------------------------------|

. 11

{5}------------------------------------------------

Kob2444
Pg6qgg

| Properties | Hi-Slip Plus<br>Hydrophilic Urinary<br>Catheter | LoFric® Primo Single<br>Use Urinary<br>Catheter, Astra<br>Tech Inc. | SpeediCath<br>Coloplast<br>Corp. |
|-----------------------|-------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| 510 (k)<br>number | | K050874 | K023254 |
| Device<br>composition | Polyvinyl chloride<br>(PVC)<br>catheter coated<br>with polyvinylpyr<br>rolidone and sterile<br>water sachet | Polyvinylchloride<br>(PVC) catheter<br>coated with<br>polyvinylpyr-<br>rolidone and salt and<br>water sachet | Polyurethane<br>catheter coated<br>with polyvinylpyr-<br>rolidone, placed in<br>a saline solution<br>containing<br>polivinyl-<br>pyrrolidone. |
| Sizes | Male 40 cm,<br>CH08-24<br>Female 20 cm,<br>CH08-18 | Male 40 cm<br>CH 10-18<br>Female 20 cm<br>CH 08-18 | Male 40 cm<br>CH08-18<br>Female 20 cm<br>CH 06-16 |
| | Boys/Pediatric<br>30 cm, CH06-10<br>Girls/Pediatric<br>20 cm, CH06-10 | Pediatric 20 cm<br>CH08-10 | Pediatric 20 cm<br>CH 06-10<br>Tiemann 40 cm<br>CH 10-14 |

| | | Table 3.3. Hi-Slip Plus-Substantial Equivalence Comparison: General | | |
|------------|--|---------------------------------------------------------------------|--|--|
| Properties | | | | |

:

{6}------------------------------------------------

K062444
pg 7 of 9

| Use | Hi-Slip Plus Hydrophilic<br>Urinary Catheter | LoFric® Primo Single<br>Use Urinary<br>Catheter, Astra<br>Tech Inc. | SpeediCath<br>Coloplast<br>Corp. |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|
| Function of<br>the<br>device | Inserted into the<br>bladder through the<br>urethra for emptying<br>the bladder | Inserted into the<br>bladder through the<br>urethra for emptying<br>the bladder | Inserted into the<br>bladder through<br>the urethra for<br>emptying the<br>bladder |
| Indication for<br>use | Intermittent<br>catheterization<br>(Because of chronic<br>urine retention and<br>other voiding<br>dysfunctions. | Intermittent<br>catheterization | Chronic urine re-<br>tention,<br>post-void residual<br>volume (PVR)<br>and voiding<br>dysfunctions. |
| Features<br>of the<br>device | Hydrophilic coated.<br>Slippery surface. Low<br>friction between<br>catheter and<br>urethral mucosa.<br>Ready to use. | Hydrophilic coated.<br>Low friction between<br>catheter<br>and urethral mucosa.<br>Ready to use. | Hydrophilic<br>coated.<br>Low friction<br>between catheter<br>and urethral<br>mucosa. Ready to<br>use. |
| Sterility | Sterile | Sterile | Sterile |
| Packaging | Peel Pack | Closed PVC | Peel Pack |

Table 3.4. Hi-Slip Plus-Substantial Equivalence Comparison: Indications for lise

:

{7}------------------------------------------------

K062444

Pg 8 of 9

| Properties: | Hi-Slip Kit-Substantial Equivalence Comparison: | | General |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Hi-Slip Hydrophilic<br>Urinary Catheter Kit | LoFric® Plus<br>Hydro-Kit II Single<br>Use Urinary<br>Catheter Astratech<br>Inc. | EasiCath Set<br>(identical to<br>the SureCath<br>Set) Coloplast<br>Corp. |
| 510 (k)<br>number | | K043241 | K973070 |
| Device<br>composition | PVC catheter coated<br>with PVP. Then sterile<br>water sachet povidone<br>iodine swab and the<br>catheter are placed<br>into the urine bag and<br>the bag is sealed. | Polyvinylchloride<br>catheter coated<br>with polyvinylpyr<br>rolidone and salt.<br>Includes water<br>sachet and urine<br>bag. | Polyvinylchloride<br>catheter coated with<br>polyvinylpyrrolidone,<br>packed<br>with an ampoule with<br>sterile saline solution and<br>sealed in a urine<br>collection bag. |
| Sizes | Male 08-18 CH<br>Female 08-16 CH<br>Pediatric Girls 06-10 CH<br>Pediatric Boys 06-10<br>CH<br>Tiemann 10-18 CH | Male CH 08-18<br>Female CH 08-18<br>Pediatric CH 06-10<br>Tiemann CH 10-18 | Male CH 08-18<br>Female CH 08-14<br>Pediatric CH 06-10 |

. . . .

### Table 3.6. Hi-Slip Kit-Substantial Equivalence Comparison: Indications for Use

| | Hi-Slip Hydrophilic<br>Urinary Catheter Kit | Lofric Plus<br>Hydro-Kit II Single<br>Use Urinary Catheter<br>Astratech Inc. | EasiCath Set<br>(identical to<br>the SureCath<br>Set) ColoplastCorp |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| Function of<br>the device | Inserted into the<br>urethra till catheter<br>reaches bladder and<br>allows urine to drain<br>into urine collection<br>bag. | Inserted into the<br>urethra till catheter<br>reaches bladder and<br>allows urine to drain<br>into urine collection<br>bag. | Inserted into the urethra<br>till catheter reaches<br>bladder and allows urine<br>to drain into urine<br>collection bag. |
| Indication<br>for use | Intermittent<br>catheterization<br>because of chronic<br>urine retention and<br>other voiding<br>dysfunctions. | Chronic urine<br>retention and<br>voiding dysfunctions. | Chronic urine retention<br>and voiding<br>dysfunctions. |
| Features<br>of the<br>device | Hydrophilic coated.<br>Slippery surface. Low<br>friction between<br>catheter and<br>urethral mucosa.<br>Ready to use. | Hydrophilic coated.<br>Low friction between<br>catheter and<br>urethral mucosa.<br>Ready to use. | Hydrophilic coated. Low<br>friction between<br>catheter and urethral<br>mucosa. Ready to use. |

{8}------------------------------------------------

K062444

Jy 9 of 9

| · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · ·<br>Sterily | and second address of there a a supportunes of<br>Sterle | a sual challed and different were any are any and<br>when and fully for the province of<br>Sterle | A FOR A MONE AND ENGINEER AND AND<br>Sterile |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Packagina | A | of the property of the country of the first of the first of the first of the first of the first of the first of the first of the first of the first of the first of the first | 200000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000 |
| | Papl | Peel Pack | 000 |
| | ปากม | assessfully and the research as a may as any assessment | a si i i i i i i a |
| | LA MA LE MINNER FOR LEASE LE / CONSULE CONSULTION CARREED IN AND AND AND AND IN AND WINNER OF | results and relation of the laboration and compress of the compress of the compress of the compress of the compress of the compress of the compress of the compressional progr | control can be and the program and the line of the line of the line of the line in the line in the line in the line in the line in the line in the line in the line in the lin |

# 3.8. Summary of Safety Testing

. . .

A summary of the safety testing performed on the coated catheter is listed below.

# Table: 3.7 Summary of Safety Tests

| Test | Reference | Results |
|--------------------------------------------------------|--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Investigaton of<br>Acute Systemic<br>Toxicity Test | Bioserv Analytik<br>Und<br>Medizinprodukte | Did not cause any acute toxicity,<br>meeting the requirements of ISO<br>10933-11 |
| Closed Patch<br>Sensitization Test | | Did not cause any sensitization,<br>meeting the requirements of DIN<br>ISO 10933-10 |
| Salmonella<br>typhimurium<br>Reverse<br>Mutation Assay | | Did not cause any genotoxic<br>activity, meeting the requirements<br>of DIN ISO 10933-3 |
| Cytotoxicity<br>Assay | | Caused no<br>toxicological/biological critical<br>cell damages and growth<br>inhibition. Under these conditions<br>the test material is considered<br>non-cytotoxic and meets the<br>requirements of DIN ISO 10993-5<br>(EN 30993-5) |
| Skin Irritation<br>Test | | Did not cause any irritation under<br>the selected test conditions<br>P.I.O.:0,0., meeting the<br>requirements of DIN ISO 10993-10 |

Conclusion: 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 -

{9}------------------------------------------------

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/9/Picture/16 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, facing left. The eagle is composed of thick, curved lines. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OASIS Medikal Ürünler c/o Mr. Charles H. Kyper Kyper & Associates 208 Barrington Overlook DURHAM NC 27703

FEB 2 2 2007

Re: K062444

Trade/Device Name: Hi-Slip Single Use Hydrophilic Urinary Catheter Hi-Slip Plus Single Use Hydrophilic Urinary Catheter with water sachet Hi-Slip Single Use Hydrophilic Urinary Catheter Kit with water sachet, urine bag and povidone iodine swab

Regulation Number: 21 CFR §876.5130

Regulation Name: Urological catheter and accessories Regulatory Class: II

Product Code: EZD Dated: January 24, 2007

Received: January 26, 2007

Dear Mr. Kyper:

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 (the Act). You may, therefore, market the device, subject to the general controls provisions of Act. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit. 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 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

{10}------------------------------------------------

Page 2 - Mr. Charles Kyper

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.

In addition, we have determined that your device kit contains a povidone iodine swab which is subject to regulation as a drug.

Our substantially equivalent determination does not apply to the drug component of your device. We recommend you first contact the Center for Drug Evaluation and Research before marketing your device with the drug component. For information on applicable Agency requirements for marketing this drug, we suggest you contact:

Director, Division of Drug Labeling Compliance (HFD-310) Center for Drug Evaluation and Research Food and Drug Administration 5600 Fishers Lane Rockville, Maryland 20857 [phone]

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, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification'' (21 CFR 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/industry/support/index.html.

Sincerely yours,

David A. Segerson

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

Enclosure

{11}------------------------------------------------

# INDICATIONS FOR USE

510(k) Number (if known): K062444

Device Name:

Hi-Slip Single Use Hydrophilic Urinary Catheter

Hi-Slip Plus Single Use Hydrophilic Urinary Catheter with water sachet

Hi-Slip Single Use Hydrophilic Urinary Catheter Kit with water sachet, urine bag and povidone iodine swab

Indications for Use:

Hi-Slip, Hi-Slip Plus and Hi-Slip Kit are launched for Clean Intermittent Catheterization-CIC treatment and is indicated for use by patients with chronic urine retention. The catheter is inserted into the bladder through the urethra for emptying the bladder.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use -(21 CFR 801 Subpart C)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Reproductive, Abdomina and Radiological Devices 510(k) Number.

Section-2, Indication for Use Statement, Page 1/1