(98 days)
No
The summary describes a surgical stapler with mechanical and electronic components, but there is no mention of AI or ML capabilities, image processing, or data-driven performance metrics.
Yes
The device is used for resection, transection, creation of anastomoses, and open occlusion of the heart's left atrial appendage, which are all therapeutic procedures.
No
The device is described as an integrated stapler for surgical procedures (resection, transection, creation of anastomoses, and occlusion), not for diagnosing conditions.
No
The device description explicitly states it is an "integrated stapler" with motors, battery, and electronics, 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 describes surgical procedures (resection, transection, creation of anastomoses, occlusion) performed on the patient's body. IVDs are used to examine specimens from the body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or treatment.
- Device Description: The device is a surgical stapler used in conjunction with reloads. This is a surgical instrument, not a diagnostic tool that analyzes biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory testing.
Therefore, this device falls under the category of a surgical instrument, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The i45, i45S, i60, i60S have applications for general and endoscopic surgery in gastrointestinal, gynecological, general abdominal, thoracic surgical procedures for resection, transection, creation of anastomoses, and for open occlusion of the heart's left atrial appendage.
Product codes
GDW
Device Description
The devices described here are reusable i45, i45S, i60, i60S used in conjunction with a variety of Reloads, which were previously cleared to market under K052415. The i45, i45S, i60, i60S are designed to be cleaned and sterilized for multi-patient use.
The i45, i45S, i60, i60S have identical technological features as the predicate devices (K003277, K021249, and K040720). The i45, i45S, i60, ions is an integrated stapler that articulates left and right. In addition to motors for stapling and cutting, and articulation, the proximal housing holds the battery and electronics enabling untethered use. Device control is managed with buttons and rocker switches on the proximal housing. The device will be steam sterilized. All product patient contact materials adhere to industry standards.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gastrointestinal, gynecological, general abdominal, thoracic, heart's left atrial appendage
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4750 Implantable staple.
(a)
Identification. An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.
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K071708
Page ① of ②
Section E
SEP 2 7 2007
Traditional 510(k) - Summary
In accordance with 21 CFR Section 807.92, Power Medical Interventions, Inc., is submitting the following 510(k) Summary:
-
- Submitter Information:
Power Medical Interventions, Inc. 2021 Cabot Blvd. West Langhorne, PA 19047 USA Ph: 267-775-8151 Fax: 267-775-8123
- Submitter Information:
Applicant: Barbara J. Whitman
Date of Notification: June 19, 2007
-
- Name of Device:
| Trade Name: | i45, i45S, i60, i60S |
|---|---|
| Common Name: | Linear Staplers with Implantable Staples |
| Classification: | Staple, Implantable, GDW |
-
- Predicate Devices:
- SurgASSIST® System with Circular Stapler Digital Loading a) Units® Power Medical Interventions, Inc., Langhorne, PA (K003277). REF PC100; RCW100; FS14, CS21, CS25, CS29, CS33.
- FlexShaft II, Power Medicai Interventions, Inc., Langhorne, PA. b) (K021249). REF FS214
- SurgASSIST® Computer Mediated Linear Cutter Digital Loading C) Units®. Power Medical Interventions, Inc., Langhorne, PA. (K040720) REF CMLC30, CMLC30, CMLC55, CMLC75.
- Device Description: 4)
The devices described here are reusable i45, i45S, i60, i60S used in conjunction with a variety of Reloads, which were previously cleared to market under K052415. The i45, i45S, i60, i60S are designed to be cleaned and sterilized for multi-patient use.
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K071708
Page ② of ②
Power Medical Interventions, Inc 145, 145s, 160, 160s 45, 1453, 100, 1000
Traditional 510(k) Premarket Notification, June 19, 2007
Device Modification: 5)
The i45, i45S, i60, i60S have identical technological features as the predicate devices (K003277, K021249, and K040720). The i45, i45S, i60, ions is an integrated stapler that articulates left and right. In addition to motors for stapling and cutting, and articulation, the proximal housing holds the battery and electronics enabling untethered use. Device control is managed with buttons and rocker switches on the proximal housing. The device will be steam sterilized. All product patient contact materials adhere to industry standards.
The predicate devices for the power, transmission, and control aspects are the PC100, previously cleared to market via K003277 and the FS214, previously cleared to market via K021249. In the predicate device, AC power was converted to 24Vdc driving DC motors. In the subject device, a battery rated at 14.8Vdc powers two DC motors directly. In the a battery ransmission of rotational power was accomplished production of a FlexShaft. In the subject device, the rotational power is transmitted through a rigid shaft. In the predicate device, control for articulation and stapling was achieved through a Remote Control Unit plugged into the Power Console. In the subject device, control is integrated into the handpiece.
The predicate device for the stapling and cutting aspects is the Computer Mediated Linear Cutter, previously cleared to market via K040720. Both the predicate and the subject devices provided 4 rows of staples with a transection in the middle. Both are steam sterilizable, multi-patient use devices.
- Indications For Use (identical to those in the predicate CMLC DLU, 6) K040720) -
The i45, i45S, i60, i60S have applications for general and endoscopic surgery in gastrointestinal, gynecological, general abdominal, thoracic surgical procedures for resection, transection, creation of anastomoses, and for open occlusion of the heart's left atrial appendage.
- Comparison to Predicate Devices
The i45, i45S, i60, i60S have the same function as the previously cleared predicate devices. The subject device provides stapling and cutting, similar to that of the CMLC, but is no longer tethered to the PC100.
The Indications For Use statement is identical to that which appears in the CMLC predicate device (K040720).
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2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures. The symbol is composed of curved lines and shapes, giving it a flowing and dynamic appearance.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Power Medical Interventions, Inc. % Peter Shearstone Sr. VP. Regulatory/Quality Assurance 2021 Cabot Boulevard West Langhorne, Pennsylvania 19047
SEP 2 7 2007
Re: K071708
Trade/Device Name: i45/i45s/i60/i60s Regulation Number: 21 CFR 878.4750 Regulation Name: Linear Stapler with Implantable Staples Regulatory Class: II Product Code: GDW Dated: September 13, 2007 Received: September 13, 2007
Dear Mr. Shearstone:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (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.
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Page 2 - Mr. Shearstone
marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson 9/26/22
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Power Medical Interventions. Inc 145. 145s. 160. 160s Traditional 510(k) Premarket Notification, June 19, 2007
Section D
Indications for Use
510(k) Number (if known): K071708
Device Name: i45, i45S, i60, i60S
Indications for Use:
The i45, i45s, i60, i60s have applications for general and endoscopic
surgery in gastrointestinal, gynecological, general abdominal, thoracic
surgical procedures for resection, transection, creation of anastomoses,
and for open occlusion of the heart's left atrial appendage.
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number K071708
| Labels | Values |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | X |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
AND/OR
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER
PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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