Instalief

K172358 · Privi Medical Pte, Ltd. · LKX · Jan 10, 2018 · GU

Device Facts

• Record ID: K172358
• Device Name: Instalief
• Applicant: Privi Medical Pte, Ltd.
• Product Code: LKX · GU
• Decision Date: Jan 10, 2018
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

Instalief is a single use device for the treatment of hemorrhoids by applying it directly to the sworthoidal tissues. By applying cold to the tissue, the inflammation is reduced. The device can be used for the treatment of external hemorrhoids and internal hemorrhoids. The device is for adults only.

Device Story

Single-use hemorrhoid cooling device; treats internal/external hemorrhoids in adults. Device components: outer bag with endothermic salt, frangible water bag, insertion tip with compliant balloon, squeezer. User bursts frangible bag to initiate endothermic reaction; inserts shaft into anal canal or applies to external tissue; uses squeezer to transfer cold fluid into balloon. Balloon provides targeted cold therapy for 6-8 minutes. Anatomical design includes tapered shaft, filleted edges, flared base to prevent over-insertion. Soft silicone rubber shaft improves comfort/safety compared to rigid predicate. Device used by patient at home. Cold therapy reduces inflammation; provides symptomatic relief.

Clinical Evidence

No clinical data. Substantial equivalence established via bench testing and biocompatibility evaluation. Bench testing included inflated static load pull tests, balloon burst volume tests, compression tests, and cold duration comparisons against the predicate. Biocompatibility testing included in-vitro cytotoxicity (elution method), skin sensitization (guinea pig maximization test), and intracutaneous reactivity (New Zealand white rabbits).

Technological Characteristics

Cold source: endothermic chemical reaction. Materials: medical-grade silicone rubber (introducer), PVC (bag). Design: tapered shaft, flared base, compliant balloon. Dimensions: 7mm OD (uninflated), 30mm max (inflated), 55mm max working depth. Single-use, non-powered, mechanical device. Biocompatibility: non-cytotoxic, non-sensitizing, non-reactive.

Indications for Use

Indicated for treatment of internal and external hemorrhoids in adults via application of cold to reduce inflammation.

Predicate Devices

• ANUICE Cryotherapy Pain Relief Products, Inc. (K981428)

Reference Devices

• GelPOINT Path Transanal Access Platform (K133393)

Submission Summary (Full Text)

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January 10, 2018

Privi Medical Pte Ltd % Alan Donald, MS, MBA, RAC President Matrix Medical Consulting, Inc. 8880 Rio San Diego Drive, Suite 800 San Diego. CA 92108

> K172358 Trade/Device Name: Instalief Regulatory Class: Unclassified Product Code: LKX Dated: December 16, 2017 Received: December 19, 2017

Dear Alan Donald:

Re:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

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(Sections 531-542 of the Act); 21 CFR 1000-1050.

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); medical device reporting of medical device-related adverse events) (21 CFR 803); 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

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

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Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K172358

Device Name Instalief

Indications for Use (Describe)

Instalief is a single use device for the treatment of hemorrhoids by applying it directly to the sworthoidal tissues. By applying cold to the tissue, the inflammation is reduced. The device can be used for the treatment of external hemorrhoids and internal hemorrhoids. The device is for adults only.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

Prescription Use (Part 21 CFR 801 Subpart D)

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

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Privi Medical Pte Ltd Instalief™ Traditional 510(k) Section 5 - Summary of Safety and Effectiveness

#### Section 5 - Summary of Safety and Effectiveness

#### 1. Submitter's Information:

Company Name: Privi Medical Pte. Ltd. Company Address: 79 Ayer Rajah Crescent #05-03, Singapore 139955 Company Phone Number: [phone] (USA) Contact: Mr. Prusothman M Sina Raja, CEO Establishment Registration Number: Not yet obtained.

Device Trade Name: Instalief™ Common Name: Hemorrhoid Cooling Device Classification Name: Device, Thermal, Hemorrhoids (LKX) Product Code: LKX

#### 2. Authorized Contact Person:

Name: Prusothman M Sina Raja Email: [e-mail], [e-mail] Telephone: [phone] (Singapore) / [phone] (USA)

#### 3. Company Device Information:

Device Name: Instalief™ Classification: Unclassified (Pre-Amendment)

#### 4. Predicate Device Information:

Device Name: ANUICE Cryotherapy Pain Relief Products, Inc. Classification: Unclassified (Pre-Amendment) 510(k): K981428 Product Code: LKX

#### 5. Submission Information:

Date Summary Prepared: 11th July 2017 Prepared by: Prusothman M Sina Raja

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## 6. Device Description

Instalief™ is a device designed for the treatment of internal and external hemorrhoids by the application of cold directly to the swollen hemorrhoidal tissue.

The device consists of an outer bag which houses an endothermic salt, a smaller water-containing frangible bag, an insertion tip with an attached compliant balloon, as well as a separate component that aids in the usage of the device, known as the squeezer.

To use the device, the user first bursts the frangible bag by pressing on it, initiating an endothermic process between the water and endothermic salt. The user then inserts the shaft of the device into the anal canal (for internal hemorrhoids) or applies to the outer tissues (for external hemorrhoids), and squeezes the bag with the aid of the squeezer. This action transfers the cold fluid generated into the balloon, which provides targeted cold therapy to the hemorrhoids. Instalief™ is meant to be used for 6 - 8 minutes.

In terms of physical characteristics, Instalief™ is anatomically designed by taking into account human anatomical characteristics. The introducer and balloon, which comes into contact with the user, is made from medical-grade material and conforms to the biocompatibility requirements of the device class. The introducer has filleted edges and a tapered shaft for smooth insertion into the anal. It is also designed with a functional length long enough to reach the internal hemorrhoids, as well as a flared base to physically prevent over-insertion. The balloon dimensions were chosen to allow for safe inflation without compromising the integrity of the material.

## 7. Indications for Use

Instalief™ is a single use device for the treatment of hemorrhoids by applying it directly to the swollen hemorrhoidal tissues. By applying cold to the tissue, the inflammation is reduced. The device can be used for the treatment of external hemorrhoids and internal hemorrhoids. The device is for adults only.

## 8. Substantial Equivalency

Instalief™ is substantially equivalent to Anuice and raises no new safety or effectiveness issues.

## 8.1. Non-Clinical Testing

The following tests were performed on Instalief™ and the predicate device (where applicable), for the comparison of functional performance and evaluation

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of both structural integrity and biocompatibility.

| Structural Integrity | |
|--------------------------------------------------------------------------|------------------------------------|
| Performance Documentation (Test<br>Protocols) | Summary of Results |
| Inflated Static Load Pull Test<br>- VV0001P | Passed |
| Balloon Burst Volume Test<br>- VV0002P | Passed |
| Compression Test (Against Predicate)<br>- VV0007P<br>- VV0009P | Both Devices Passed |
| Functional Performance | |
| Performance Documentation (Test<br>Protocols) | Summary of Results |
| Cold Duration Test (Against Predicate)<br>- VV0003P<br>- VV0008P | Cold duration similar to predicate |
| Biocompatibility | |
| Test Information and Details | Summary of Results |
| In-vitro cytotoxicity – Elution method | Non-cytotoxic |
| Skin sensitization test in guinea pigs (guinea<br>pig maximization test) | Non-sensitizing |
| Intracutaneous reactivity test in New Zealand<br>white rabbits | Non-reactive |

#### 8.2. Clinical Testing

Clinical testing is not applicable for establishing substantial equivalence of Instalief™.

## 8.3. Comparison Table of New and Predicate Device

| | Features and Specifications | InstaliefTM | Anuice | Notes |
|----|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | Mode of action | Application of cold to hemorrhoidal tissue | Application of cold to hemorrhoidal tissue | Same |
| 2 | Max insertion | Up to 25mm into | Up to 45mm into | Smaller initial insertion |
| | depth | the anal canal (for<br>internal<br>hemorrhoids) | the anal canal (for<br>internal<br>hemorrhoids) | depth for Instalief™ |
| | | | | |
| 3 | Max working<br>depth | Up to 55mm into<br>the anal canal (for<br>internal<br>hemorrhoids) | Up to 45mm into<br>the anal canal (for<br>internal<br>hemorrhoids) | Both depths are in similar<br>range. The slightly deeper<br>working depth ensures<br>better coverage of<br>hemorrhoidal region. |
| 4 | Insertion depth<br>limiter | Flared base<br>component | Flared base<br>component | Same. Both designed to<br>physically limit insertion<br>depth. |
| 5 | Insertion OD | 7 mm (without<br>balloon inflation)<br>30 mm maximum<br>(with balloon<br>inflation) | 11mm | A smaller insertion OD<br>allows for easier and more<br>comfortable insertion and<br>removal.<br>The balloon is expanded<br>after insertion into the anal<br>canal, and is deflated prior<br>to being withdrawn. |
| 6 | Cold source | Chemical<br>(endothermic<br>process) | Physical (phase<br>change) | Similar. In Instalief™, the<br>cold source is generated<br>through an endothermic<br>reaction, while the predicate<br>device achieves this through<br>a physical change of state of<br>its contained substance.<br>Both devices function using<br>the principle of cold<br>therapy. |
| 7 | Shaft material | Silicone Rubber<br>(introducer) | Rigid plastic | Soft flexible shaft reduces<br>the risk of tissue damage<br>caused by erroneous<br>insertion technique |
| 8 | Cold therapy<br>delivery | Delivered via a<br>compliant balloon | Delivered via a<br>hollow shaft | The balloon is a better cold<br>therapy delivery component<br>as it conforms to the shape<br>of the anal canal |
| 9 | Removal<br>mechanism | Deflate balloon<br>followed by<br>withdrawal | Withdrawal of<br>device | Similar |
| 10 | Base | PVC Bag | Hard plastic | Bag is designed to |
| | | | | withstand the require back<br>pressure during usage (see<br>VV0007P) |
| 11 | Anatomically<br>designed | Yes. General design<br>characteristics:<br>1. Tapered shaft<br>extending into anal<br>canal<br>2. “Base” feature to<br>prevent over-<br>insertion of device<br>3. Smooth rounded<br>corners<br>4. No sharp edges | Yes. General<br>design<br>characteristics:<br>1. Tapered shaft<br>extending into<br>anal canal<br>2. “Base” feature<br>to prevent over-<br>insertion of<br>device<br>3. Smooth<br>rounded corners<br>4. No sharp edges | Same. Similar design<br>characteristics meant to<br>facilitate insertion<br>into/removal out of the anal<br>canal. |

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# Privi Medical Pte Ltd
Instalief™

Traditional 510(k) Section 5 - Summary of Safety and Effectiveness

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## Privi Medical Pte Ltd Instalief™ Traditional 510(k)

Section 5 - Summary of Safety and Effectiveness

- 8.4. Studies Cited for Substantial Equivalence Discussion
- 8.4.1. Ratuapli, M. D. et al.(2013). Comparison of rectal balloon expulsion test in seated and left lateral positions. Neorugastroenterol Motil. 25(12). Doi:10.1111/nmo.12208
- 8.4.2. Padda, B. S. et al. (2006). Effects of pelvic floor muscle contraction on anal canal pressure. Am J Physiol Gastrointest Liver Physiol. 292: G565-G571. Doi:10.1152/ajpgi.00250.2006
- 8.4.3. Duthie, H. L., Bennett, R. C. (1963). The relation of sensation in the anal canal to the functional anal sphincter: a possible factor in anal continence. Gut,4, 179-182. Doi:10.1136/gut.4.2.179
- 8.5. Referenced Devices
- 8.5.1. GelPOINT Path Transanal Access Platform (K133393)

## 9. Conclusion

Based on the comparison of intended use, indications for use, non-clinical testing, literature, biocompatibility testing and technological characteristics, the Instalief™ is substantially equivalent to Anuice (K981428) and raises no new safety or effectiveness issues.