Autoclavable Suction Jar with Luer Lock extension - 250, 500, 1,000, 2,000 and 3,000 ml, Autoclavable Suction Jar without Luer Lock extension - 1,500 and 2,500 ml, Sterile 1,500 and 2,500 Lids with Conical patient connection 6-10 and overflow protection

K170449 · Millennium Medical Technologies, Inc. · MUU · Mar 31, 2017 · General, Plastic Surgery

Device Facts

• Record ID: K170449
• Device Name: Autoclavable Suction Jar with Luer Lock extension - 250, 500, 1,000, 2,000 and 3,000 ml, Autoclavable Suction Jar without Luer Lock extension - 1,500 and 2,500 ml, Sterile 1,500 and 2,500 Lids with Conical patient connection 6-10 and overflow protection
• Applicant: Millennium Medical Technologies, Inc.
• Product Code: MUU · General, Plastic Surgery
• Decision Date: Mar 31, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.5040
• Device Class: Class 2

Intended Use

The Millennium Medical Technologies, Inc. Collection Jars and Lids are used in conjunction with hospital or surgery center vacuum and/or cleared pumps, tubing and cannulas, for the collection of aspirated fat, for aesthetic body contouring. If the fat is untreated, it may be re-injected via a cleared injection apparatus.

Device Story

Device consists of autoclavable polycarbonate suction jars (250-3000 mL) and sterile polypropylene lids with liners. Used in hospital/surgery centers by clinicians with vacuum pumps, tubing, and cannulas for fat aspiration. Jars collect fat via vacuum; some models feature a stainless steel luer fitting at the base to facilitate transfer of untreated fat for re-injection. Lids include overflow protection and conical patient connections. Device enables fat collection and subsequent autologous fat transfer. Benefits include reusable, autoclavable components and integrated luer-lock transfer capability.

Clinical Evidence

No clinical data. Bench testing only: biocompatibility (ISO MEM Elution, Intracutaneous Irritation, Acute Systemic Injection, Guinea Pig Maximization), leakage testing, compatibility testing, and sterilization validation (Gamma irradiation per ISO 11137-1; gravity autoclave cleaning/sterilization per AAMI TIR30 and ISO 17665-1).

Technological Characteristics

Materials: medical grade polycarbonate (jars), medical grade polypropylene (lids), medical grade silicone (tubing). Energy: vacuum-driven (external pump). Form factor: 250-3000 mL canisters. Sterilization: Gamma irradiation (lids/liners); autoclavable (jars). Connectivity: None.

Indications for Use

Indicated for use in hospital or surgery center settings for the collection of aspirated fat during aesthetic body contouring procedures. Untreated fat may be re-injected using a cleared injection apparatus.

Regulatory Classification

Identification

A suction lipoplasty system is a device intended for aesthetic body contouring. The device consists of a powered suction pump (containing a microbial filter on the exhaust and a microbial in-line filter in the connecting tubing between the collection bottle and the safety trap), collection bottle, cannula, and connecting tube. The microbial filters, tubing, collection bottle, and cannula must be capable of being changed between patients. The powered suction pump has a motor with a minimum of 1/3 horsepower, a variable vacuum range from 0 to 29.9 inches of mercury, vacuum control valves to regulate the vacuum with accompanying vacuum gauges, a single or double rotary vane (with or without oil), a single or double diaphragm, a single or double piston, and a safety trap.

Special Controls

*Classification.* Class II (special controls). Consensus standards and labeling restrictions.

Predicate Devices

• Tissu-Trans Filtron (K092482)

Submission Summary (Full Text)

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March 31, 2017

Millennium Medical Technologies, Inc. Mr. Jim Barley Director of Regulatory Affairs 6352 Corte Del Abeto Suite A Carlsbad, California 92011

Re: K170449

Trade/Device Name: Autoclavable Suction Jar With Luer Lock Extension - 250, 500, 1,000, 2,000 And 3,000 Ml, Autoclavable Suction Jar Without Luer Lock Extension - 1,500 And 2,500 Ml, Sterile 1,500 And 2,500 Lids With Conical Patient Connection 6-10 And Overflow Protection Regulation Number: 21 CFR 878.5040 Regulation Name: Suction Lipoplasty System Regulatory Class: Class II Product Code: MUU Dated: January 27, 2017 Received: February 15, 2017

Dear Mr. Barley:

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.

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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); medical device reporting (reporting of medical devicerelated 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 (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

# Jennifer R. Stevenson -S

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

#### 510(k) Number (if known)

#### K170449

Device Name

· MMT Autoclavable Suction Jar with Luer Lock extension- 250, 500, 1.000, 2.000 and 3.000 ml.

· MMT Autoclavable Suction Jar - 1.500 and 2.500 ml

· MMT Sterile and non sterile 1,500 Lids with Conical patient connection 6-10 and overflow protection

#### Indications for Use (Describe)

The Millennium Medical Technologies, Inc. Autoclavable Suction Jars and Lids are used in conjunction with hospital or surgery center vacuum and/or cleared pumps, tubing and cannulas, for the collection of aspirated fat, for aesthetic body contouring. If the fat is untreated, it may be reinjected via a cleared injection apparatus.

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

#### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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### FAT COLLECTION AND TRANSFER DEVICES

## 510(k) Summary (As required by 21 CFR 807.92(a))

### Applicant and Correspondent

| Name: | Millennium Medical Technologies, Inc. | |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Address: | 6352 Corte Del Abeto, Ste. A<br>Carlsbad, CA 92011 | |
| Contact: | Greg Miles | |
| Phone Numbers: | [phone] (Voice) | |
| Date of Preparation: | March 10, 2017 | |
| Manufacturer | Millennium Medical Technologies, Inc. | |
| | 6352 Corte Del Abeto, Ste. A<br>Carlsbad, CA 92011 | |
| Registration#: | 2032809 | |
| Name of Device | Trade/Proprietary/Model Name:<br>- MMT line of Collection Jars & Transfer Devices<br>- Autoclavable Suction Jars and Lids with Luer Lock extension and extraction tube - 250, 500, 1,000, 2,000 and 3,000 ml<br>- Suction Jar without Luer Lock extension - 1,500 and 2,500 ml<br>- Sterile 1,500 ml and 2,500 ml Lids with Liner and Conical patient connection 6-10 and overflow protection | |
| Common Name: | Fat Collection and Transfer Devices | |
| Classification Name: | Suction Lipoplasty System | |
| Classification Regulation: | 878.5040 | |
| Panel: | General and Plastic Surgery | |
| Product Code: | MUU | |
| Recognized Performance Std: | None | |

## Device to Which New Device is Substantially Equivalent

| Device Name: | Tissu-Trans Filtron |
|---------------|-------------------------------------|
| Manufacturer: | Shippert Medical Technologies, Inc. |

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FAT COLLECTION AND TRANSFER DEVICES K092482

#### Reference:

#### 510(k) SUMMARY (Continued)

#### Device Description

The Millennium Medical Technologies line of Fat Collection and Transfer Devices consist of the following:

- 1. Autoclavable Suction Jars and lids with Luer Lock extension and extraction tub - 250, 500, 1,000, 2,000 and 3,000 ml
- 2. Suction Jar without Luer Lock extension 1,500 and 2,500 ml
- 3. Sterile 1,500 and 2,500 ml Lids with Conical patient connection 6-10 and overflow protection

The Millennium Medical Technologies Collection Jars are Suction Canisters molded from medical grade polycarbonate. The 250, 500, 1,000, 2,000 and 3,000 ml canisters have a stainless steel luer fitting at its base to facilitate the transfer of untreated fat back into the patient using a cleared injection apparatus. The 1,500 and 2.500 ml canisters are designed to interface with the Lid with Liner and do not have a fitting at the base of the canister. All of the Collection Jars are provided non-sterile and are autoclavable.

The Millennium Medical Technologies Small and Large Lids are molded from medical grade polypropylene and have various ports, medical grade silicone tubing and a liner to contain all waste. The Large Lid has a 6-10 tapered cone for the 2,500 ml canister and the Small Lid has a 6-10 tapered cone for the 1,500 ml canister. The Lids with Liner are provided sterile.

#### Statement of Intended Use

The Millennium Medical Technologies, Inc. Collection Jars and Lids are used in conjunction with hospital or surgery center vacuum and/or cleared pumps, tubing and cannulas, for the collection of aspirated fat, for aesthetic body contouring. If the fat is untreated, it may be re-injected via a cleared injection apparatus.

#### Summary of Technological Characteristics

The Intended Use statement of the MMT Collection Jars and Lids with Liners is identical to that of the predicate. The materials of construction used in the MMT Collection Jars and Lids with Liners are identical to those of the predicate device. Performance testing has demonstrated that the products' efficacy and effectiveness is substantially equivalent to the predicate device.

A comparison of the MMT Collection Jars and Lids with Liners to the predicate device, the Shippert Medical Technologies Collection Jars and Lids with Liners is given in Table 1

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## FAT COLLECTION AND TRANSFER DEVICES

| | Parameter Description | Predicate Device:<br>SMT Tissu Trans Filtron | Subject Device:<br>MMT Fat Collection and Transfer System | Comparison of<br>Subject<br>Device to<br>Predicate |
|-------------------------------|-----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------|
| Technological Characteristics | FDA Predicate # | K092482 | K170449 | N/A |
| | Product Code | MUU | MUU | Same |
| | Clearance Date | 12/4/2009 | TBD | N/A |
| | Indication for Use | The Tissu Trans Filtron is<br>intended to be used with house<br>vacuum and/or cleared pumps,<br>tubing and cannulas, for the<br>collection of aspirated fat, for<br>aesthetic body contouring. If<br>the fat is untreated, it may be<br>re-injected via a cleared<br>injection apparatus. | The Millennium Medical Technologies,<br>Inc.(MMT) Fat Collection and Transfer<br>Devices are intended to be used with house<br>vacuum and/or cleared pumps, tubing and<br>cannulas, for the collection of aspirated fat,<br>for aesthetic body contouring. If the fat is<br>untreated, it may be re-injected via a<br>cleared injection apparatus. | Same |
| | Description | The Tissu Trans Fltron is<br>provided in a sterile, two piece<br>packaged assembly. The Tissu<br>Trans Filtron. The Tissu Trans<br>Filtron is a single-use, sterile,<br>disposable device designed to<br>utilize an FDA cleared house<br>vacuum to create suction within<br>the physician supplied hollow<br>liposuction and remove<br>subcutaneous fatty tissue from<br>the patient and transport the<br>autologous tissue into the<br>collection canister. | The Millennium Medical Technologies<br>Collection Jars are suction canisters<br>molded from medical grade polycarbonate.<br>The 250, 500, 1,000, 2,000 and 3,000 ml<br>canisters are provided non-sterile and are<br>autoclavable. Each Collection Jar has a<br>stainless steel luer fitting at its base to<br>facilitate the transfer of untreated fat back<br>into the patient using a cleared injection<br>apparatus.<br>The 1,500 and 2,500 ml collection jars are<br>also molded from medical grade<br>polycarbonate and are used with the MMT<br>Lids with Liners. The 1,500 and 2,500 ml<br>collection jars are autoclavable.<br>The Millennium Medical Technologies<br>Small and Large Lids are molded from<br>medical grade polypropylene and have<br>various ports, medical grade silicone<br>tubing and a liner to contain all waste.<br>The Large Lid has a 6-10 tapered cone<br>for the 2,500 ml canister and the Small<br>Lid has a 6-10 tapered cone for the<br>1,500 ml canister. The Lids are<br>provided sterile. | Similar<br>and SE |
| | Parameter Description | Predicate Device:<br>SMT Tissu Trans Filtron | Subject Device:<br>MMT Fat Collection and Transfer System | Comparison<br>on of<br>Subject<br>Device to<br>Predicate |
| Specification | Autoclavable<br>Collection Jars for<br>Lids w/Liner | 500, 1,000 and 2,000 Liners | 1,500 and 2,500 Liners | SE |
| | Autoclavable<br>Collection Jars | 250, 500, 1,000, 2,000 and<br>3,000 ml | 250, 500, 1,000, 2,000 and 3,000 ml | Same |
| | Collection Jar<br>Lids | Large and Small Lids | Large and Small Lids | Same |
| Style | Collection Jar rim<br>diameter | 2 sizes | 2 sizes | Same |
| | Design | Jar with handle | Jar with handle | Same |
| | Scale units | mL | mL | Same |
| | Port at base of<br>Collection Jar | No | Yes | Different |
| Other<br>Features | Method to<br>separate waste<br>from fat | Vacuum fat through filter | Gravity | Different |
| | Waste Jar<br>required | Yes | No | Different |
| How<br>Supplied | Non-Sterile | Collection Jars | Collection Jars | Same |
| | Sterile | Collection Jar with Lid and<br>Filter | Lid with Bag Liner | Different |

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### FAT COLLECTION AND TRANSFER DEVICES

## Brief description of the nonclinical tests submitted, referenced, or relied on in the premarket notification submission for a determination of substantial equivalence.

- The following biocompatibility tests were conducted on the MMT Fat Collection and Transfer Devices:
- o ISO MEM Elution Using L-329 Mouse Fibroblast Cells
- o ISO Intracutaneous Irritation Test
- ISO Acute Systemic Injection Test o
- o ISO Guinea Pig Maximization Sensitization Test

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FAT COLLECTION AND TRANSFER DEVICES

- · The MMT Fat Collection and Transfer Devices were tested for leakage and compatibility of Collection Jars with Lids and Liners. In addition, the accuracy of the MMT) Fat Collection and Transfer Devices was compared to the comparative predicate device.
- · For the product supplied sterile, Millennium Medical conducted a Gamma Irradiation Sterilization Validation per the requirements of ISO 11137-1:2006;Amd. 1, 2013.
- For the autoclavable product;
- A Cleaning Validation was performed in accordance with the AAMI O TIR30:2011 Guidance document. The Cleaning Validation was conducted to ensure that once the device has been used, it can be properly cleaned for resterilization.
- o A Sterilization Validation for a gravity autoclave was conducted per the requirements of TIR N0. 12-2004 and ISO 17665-1:2006/(R) 2013. The product was prepared with a resistant organism at a population of 1.0 X 106 colony forming units (CFU), subjected to a gravity autoclave cycle at one half the intended time for resterilization, then sterility tested. In addition, the 10 minute default autoclave drying cycle was qualified.

## Brief discussion of clinical tests submitted, referenced, or relied on in the premarket notification submission for a determination of substantial equivalence.

Not applicable.

## Conclusion drawn for the nonclinical and clinical tests

The MMT Fat Collection and Transfer Devices have the same intended use and technological characteristics as the predicate device, Shippert Medical Technologies. The materials of construction used in the MMT) Fat Collection and Transfer Devices are substantially equivalent to those of the predicate device. Performance testing has demonstrated the product's efficacy. The MMT) Fat Collection and Transfer Devices have been demonstrated to be substantially equivalent to the predicate device.