(147 days)
K130435 Covidien Versaport V2 Bladeless Optical Trocar (5-mm trocars)
No
The 510(k) summary describes a mechanical surgical instrument (trocar) and its reprocessing. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
A therapeutic device is one that treats a disease or condition. This device, a trocar, is used to create and maintain a port of entry for other instruments during endoscopic procedures; it does not directly treat a disease or condition.
No
This device is not a diagnostic device; it is a surgical tool (trocar) intended to create and maintain a port of entry during endoscopic procedures. Its function is to facilitate access for other instruments, not to diagnose medical conditions.
No
The device description clearly outlines physical components like a transparent cannula, obturator, obturator housing, and trocar housing, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for creating and maintaining a port of entry during surgical procedures. This is a surgical instrument used in vivo (within the body), not a device used in vitro (outside the body) to examine specimens like blood, urine, or tissue for diagnostic purposes.
- Device Description: The description details a physical instrument with a cannula and obturator for surgical access. This aligns with a surgical tool, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on laboratory tests.
Therefore, the Medline ReNewal Reprocessed Versaport V2 Bladeless Optical Trocar is a surgical device, not an IVD.
N/A
Intended Use / Indications for Use
The Medline ReNewal Reprocessed Versaport V2 Bladeless Optical Trocar is intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entry. The trocar may be used with or without visualization for primary and secondary insertions.
Product codes (comma separated list FDA assigned to the subject device)
NLM
Device Description
The Medline ReNewal Reprocessed Versaport V2 Bladeless Optical Trocar 5-mm, 11-mm and 12-mm, with transparent cannula and obturator, allows optical entry for visualization of tissue layers during insertion. It is available in standard (100 mm), short (70 mm) and long (150 mm) cannula lengths. The obturator housing contains a scope retention mechanism and the trocar housing contains internal seals to prevent loss of pneumoperitoneum when instruments are inserted into a port or withdrawn completely from a port. The 5-mm, 11-mm and 12-mm Versaport seal system accommodate instruments indicated as 5-mm up to 11-mm and 12-mm respectively.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The functional characteristics of the proposed device have been evaluated and were found to be substantially equivalent to the predicate device based on the following tests:
- Simulated use and artificial soiling;
- Functional performance studies:
- Seal leakage;
- Seal drag;
- Surface roughness;
- Visualization.
- Cleaning:
- Protein and carbohydrates;
- Visual inspection;
- Cleaning performance qualification.
- Biocompatibility:
- Cytotoxicity (direct and in-direct patient contacting);
- Irritation (direct and in-direct patient contacting);
- Sensitization (direct and in-direct patient contacting);
- Material-mediated pyrogenicity (direct and in-direct patient contacting); and
- Acute systemic toxicity (direct and in-direct patient contacting).
- Sterilization and packaging validations:
- Bioburden enumeration testing;
- Ethylene oxide and ethylene chlorohydrin residuals testing
- Product stability.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K112349 Covidien Versaport V2 Bladeless Optical Trocar (11-mm and 12-mm trocars)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K130435 Covidien Versaport V2 Bladeless Optical Trocar (5-mm trocars)
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
0
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and features the department's name around the perimeter. In the center is a stylized design of a human figure, represented by three overlapping profiles, with a wing-like shape extending from the head.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 5, 2016
Surgical Instrument Service and Savings Ms. Brandi Panteleon Director, Quality Assurance and Regulatory Affairs 2747 SW 6th St. Redmond, Oregon 97756
Re: K153258
Trade/Device Name: Medline Renewal Reprocessed Versaport V2 Bladeless Optical Trocars Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: NLM Dated: March 7, 2016 Received: March 8, 2016
Dear Ms. Panteleon:
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. 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Jennifer R. Stevenson -A
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
2
| Manufacturer
| Model No. | Description | Diameter x Length |
|---|---|---|
| ONB5STF | Optical bladeless Standard Trocar with | |
| Fixation Cannula | 5- x 100-mm | |
| ONB5SHF | Optical bladeless Short Trocar with Fixation | |
| Cannula | 5- x 70-mm | |
| ONB5LGF | Optical bladeless Standard Trocar with | |
| Fixation Cannula | 5- x 150-mm | |
| ONBFCA5LG | Long Fixation Cannula | 5- x 150-mm |
| ONBFCA5SH | Short Fixation Cannula | 5- x 70-mm |
| ONBFCA5ST | Standard Fixation Cannula | 5- x 100-mm |
| ONB11STF | Optical bladeless Standard Trocar with | |
| Fixation Cannula | 11-x 100-mm | |
| ONB11LGF | Optical bladeless Long Trocar with Fixation | |
| Cannula | 11-x 150-mm | |
| ONBFCA11ST | Standard Fixation Cannula | 11-x 100-mm |
| ONB12STF | Optical bladeless Standard Trocar with | |
| Fixation Cannula | 12- x 100-mm | |
| ONB12LGF | Optical bladeless Long Trocar with Fixation | |
| Cannula | 12- x 150-mm | |
| ONB12SHF | Optical bladeless Short Trocar with Fixation | |
| Cannula | 12- x 70-mm | |
| ONB12STS | Optical bladeless Standard Trocar with | |
| Smooth Cannula | 12- x 100-mm | |
| ONBFCA12ST | Standard Fixation Cannula | 12- x 100-mm |
| ONBFCA12LG | Long Fixation Cannula | 12- x 150-mm |
Reprocessed Single-Use Device Models Included in Clearance:
3
Indications for Use
510(k) Number (if known) K153258
Device Name
Medline ReNewal Reprocessed Versaport V2 Bladeless Optical Trocar
Indications for Use (Describe)
The Medline ReNewal Reprocessed Versaport V2 Bladeless Optical Trocar is intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entry. The trocar may be used with or without visualization for primary and secondary insertions.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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FOR FDA USE ONLY
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Image /page/4/Picture/0 description: The image shows the Medline Renewal logo. The word "Medline" is in blue, with a blue star-like symbol to the left of it. To the right of "Medline" is a vertical line, followed by the word "Renewal" in green and blue. Below "Renewal" is the phrase "Full Circle Reprocessing" in a smaller font.
510(k) Summary K153258
| Submitter/
Owner | Medline ReNewal
2747 SW 6th St.
Redmond, OR 97756 |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Name | Brandi Panteleon
Director, QA/RA
P: 541-516-4180
F: 541-923-3375
E: bpanteleon@medline.com |
| Prepared by | Stephanie Mays
Technical Writer
P: 541-516-4205
F: 541-923-3375
E: smays@medline.com |
| Date Prepared | November 9, 2015 |
| Device Names | Proprietary Name: Medline ReNewal Reprocessed Versaport V2
Bladeless Optical Trocar
Common Name: Surgical Trocar |
| Classification | Laparoscope, General & Plastic Surgery, Reprocessed
Product code: NLM
Class: Class II, non-exempt
Classification Number: 21 CFR § 876.1500 |
| Predicate Device | K112349 Covidien Versaport V2 Bladeless Optical Trocar (11-mm and 12-
mm trocars) |
| Reference
Device | K130435 Covidien Versaport V2 Bladeless Optical Trocar (5-mm trocars) |
| Device
Description | The Medline ReNewal Reprocessed Versaport V2 Bladeless Optical
Trocar 5-mm, 11-mm and 12-mm, with transparent cannula and obturator,
allows optical entry for visualization of tissue layers during insertion. It is
available in standard (100 mm), short (70 mm) and long (150 mm) cannula
lengths. The obturator housing contains a scope retention mechanism and
the trocar housing contains internal seals to prevent loss of
pneumoperitoneum when instruments are inserted into a port or withdrawn
completely from a port. The 5-mm, 11-mm and 12-mm Versaport seal
system accommodate instruments indicated as 5-mm up to 11-mm and
12-mm respectively. |
| Intended Use | The Medline ReNewal Reprocessed Versaport V2 Bladeless Optical
Trocar is intended for use in a variety of gynecologic, general, thoracic and
urologic endoscopic procedures to create and maintain a port of entry. The
trocar may be used with or without visualization for primary and secondary
insertions. |
| Technological
Characteristics | The technological characteristics and the fundamental scientific
technology of the subject device are identical to the predicate device. The
proposed device is a reprocessed version of the predicate device. |
5
Image /page/5/Picture/0 description: The image shows the Medline Renewal logo. The word "MEDLINE" is in blue, with a blue star symbol to the right of it. To the right of the Medline logo is a vertical line, followed by the word "Renewal" in green and blue. Below "Renewal" are the words "Full Circle Reprocessing" in a smaller font.
The functional characteristics of the proposed device have been evaluated and were found to be substantially equivalent to the predicate device based on the following tests:
- Simulated use and artificial soiling;
- Functional performance studies:
- Seal leakage; O
- Seal drag; O
- Surface roughness; O
- Visualization. O
- Seal leakage; O
- Cleaning:
O
.
- Protein and carbohydrates; o
- Visual inspection;
Performance Testing
- O Cleaning performance qualification.
- Biocompatibility:
- Cytotoxicity (direct and in-direct patient contacting); O
- Irritation (direct and in-direct patient contacting); O
- Sensitization (direct and in-direct patient contacting); O
- Material-mediated pyrogenicity (direct and in-direct patient O contacting); and
- Acute systemic toxicity (direct and in-direct patient O contacting).
- . Sterilization and packaging validations:
- O Bioburden enumeration testing;
- O Ethylene oxide and ethylene chlorohydrin residuals testing
- . Product stability.
| | Manufacturer
Model No. | Description | Diameter x
Length |
|---------------|---------------------------|------------------------------------------------------------|----------------------|
| Device models | ONB5STF | Optical bladeless Standard Trocar
with Fixation Cannula | 5- x 100-mm |
| | ONB5SHF | Optical bladeless Short Trocar with
Fixation Cannula | 5- x 70-mm |
| | ONB5LGF | Optical bladeless Standard Trocar
with Fixation Cannula | 5- x 150-mm |
| | ONBFCA5LG | Long Fixation Cannula | 5- x 150-mm |
| | ONBFCA5SH | Short Fixation Cannula | 5- x 70-mm |
| | ONBFCA5ST | Standard Fixation Cannula | 5- x 100-mm |
| | ONB11STF | Optical bladeless Standard Trocar
with Fixation Cannula | 11- x 100-mm |
| | ONB11LGF | Optical bladeless Long Trocar with
Fixation Cannula | 11- x 150-mm |
| | ONBFCA11ST | Standard Fixation Cannula | 11- x 100-mm |
| | ONB12STF | Optical bladeless Standard Trocar
with Fixation Cannula | 12- x 100-mm |
| | ONB12LGF | Optical bladeless Long Trocar with
Fixation Cannula | 12- x 150-mm |
| | ONB12SHF | Optical bladeless Short Trocar with
Fixation Cannula | 12- x 70-mm |
| | ONB12STS | Optical bladeless Standard Trocar
with Smooth Cannula | 12- x 100-mm |
| | ONBFCA12ST | Standard Fixation Cannula | 12- x 100-mm |
| | ONBFCA12LG | Long Fixation Cannula | 12- x 150-mm |
6
Image /page/6/Picture/0 description: The image shows the Medline Renewal logo. The Medline logo is on the left, and the Renewal logo is on the right. The Renewal logo is green and blue, and the text "Full Circle Reprocessing" is below the Renewal logo.
In accordance with 21 CFR Part 807, and based on a comparison of 'Indications for Use,' technological characteristics and performance data, Conclusion Medline ReNewal concludes that the proposed Medline ReNewal Reprocessed Versaport V2 Bladeless Optical Trocar is substantially equivalent to the predicate device.
7
Image /page/7/Picture/0 description: The image contains the Medline Renewal logo. The Medline logo is a blue star with the word "MEDLINE" in blue letters next to it. The Renewal logo is in green and blue letters, with the words "Full Circle Reprocessing" in smaller letters below. The logo is simple and professional, and it is likely used to promote Medline Renewal's products or services.
Predicate, Reference, and Medline ReNewal Reprocessed Covidien Versaport V2 Bladeless Optical Trocar device comparison chart.
| | Predicate Device | Reference Device | Proposed Device | Comparison
Analysis |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| Device Characteristic | Covidien Versaport
Bladeless Optical Trocar | Covidien Versaport V2
Bladeless Optical Trocar | Medline ReNewal Versaport
Bladeless Optical Trocar | |
| 510(k) Number | K112349 | K130435 | K153258 | NA |
| Intended
Use/Indications for Use | The Versaport Bladeless
Optical Trocar is intended for
use in a variety of gynecologic,
general, thoracic and urologic
endoscopic procedures to
create and maintain a port of
entry. The trocar may be used
with or without visualization for
primary and secondary
insertions. | The Versaport V2 Bladeless
Optical Trocar is intended for
use in a variety of gynecologic,
general, thoracic and urologic
endoscopic procedures to
create and maintain a port of
entry. The trocar may be used
with or without visualization for
primary and secondary
insertions. | The Medline ReNewal
Reprocessed Versaport
Bladeless Optical Trocar is
intended for use in a variety of
gynecologic, general, thoracic
and urologic endoscopic
procedures to create and
maintain a port of entry. The
trocar may be used with or
without visualization for
primary and secondary
insertions. | Same |
| Design Configuration
and Model | 5-mm diameter in models:
ONB5STF (100 mm)
ONB5SHF (70 mm)
ONB5LGF (150 mm)
ONBFCA5LG (150 mm)
ONBFCA5SH (70 mm)
ONBFCA5ST (100 mm) | NA | 5-mm diameter in models:
ONB5STF (100 mm)
ONB5SHF (70 mm)
ONB5LGF (150 mm)
ONBFCA5LG (150 mm)
ONBFCA5SH (70 mm)
ONBFCA5ST (100 mm) | same |
| | NA | 11-mm diameter in models:
ONB11STF (100 mm)
ONB11LGF (150 mm)
ONBFCA11ST (100 mm) | 11-mm diameter in models:
ONB11STF (100 mm)
ONB11LGF (150 mm)
ONBFCA11ST (100 mm) | Same |
Continued
8
Image /page/8/Picture/0 description: The image shows the Medline Renewal logo. The Medline logo is on the left, and the Renewal logo is on the right. The Renewal logo is green and blue, and the words "Full Circle Reprocessing" are below it.
Predicate, Reference, and Medline ReNewal Reprocessed Covidien Versaport Bladeless Optical Trocar device comparison chart (concluded).
| Device Characteristic | Predicate Device | Reference Device | Proposed Device | Comparison
Analysis |
|-----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| | Covidien Versaport V2
Bladeless Optical Trocar | Covidien Versaport V2
Bladeless Optical Trocar | Medline ReNewal Versaport
Bladeless Optical Trocar | |
| Design Configuration
and Model (concluded) | NA | 12-mm diameter in models:
ONB12STF (100 mm)
ONB12LGF (150 mm)
ONB12SHF (70 mm)
ONB12STS (100 mm)
ONBFCA12ST (100 mm)
ONBFCA12LG (150 mm) | 12-mm diameter in models:
ONB12STF (100 mm)
ONB12LGF (150 mm)
ONB12SHF (70 mm)
ONB12STS (100 mm)
ONBFCA12ST (100 mm)
ONBFCA12LG (150 mm) | Same |
| Technological
Characteristics | Transparent cannula,
bladeless obturator with
transparent optical window at
distal end, obturator housing
scope retention mechanism
and external interlocking
snaps.
Scope retention mechanism is
within the obturator housing for
secured insertion and retention
of appropriately sized 0°
laparoscope for visualization of
tissue layers during insertion
into body cavity.
Three-way stopcock for
insufflation and rapid
desufflation. External
interlocking snaps secure | Transparent cannula,
bladeless obturator with
transparent optical window at
distal end, obturator housing
scope retention mechanism
and external interlocking
snaps.
Scope retention mechanism is
within the obturator housing for
secured insertion and retention
of appropriately sized 0°
laparoscope for visualization of
tissue layers during insertion
into body cavity.
Three-way stopcock for
insufflation and rapid
desufflation. External
interlocking snaps secure | Transparent cannula,
bladeless obturator with
transparent optical window at
distal end, obturator housing
scope retention mechanism
and external interlocking
snaps.
Scope retention mechanism is
within the obturator housing for
secured insertion and retention
of appropriately sized 0°
laparoscope for visualization of
tissue layers during insertion
into body cavity.
Three-way stopcock for
insufflation and rapid
desufflation. External
interlocking snaps secure | Same |